U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
Reason
Cook, inc. is recalling single, double, triple, and five-lumen central venous catheter trays and single and double lumen picc peripherally inserted central venous catheter trays. these kits and trays contain 0.9% sodium chloride injection usp 5 ml fill in 6 ml flush syringes that have been recalled by excelsior medical. during a routine test for syringe sterility, a possible integrity failure wa.
Action
Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
Reason
Cook, inc. is recalling single, double, triple, and five-lumen central venous catheter trays and single and double lumen picc peripherally inserted central venous catheter trays. these kits and trays contain 0.9% sodium chloride injection usp 5 ml fill in 6 ml flush syringes that have been recalled by excelsior medical. during a routine test for syringe sterility, a possible integrity failure wa.
Action
Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Electrode, ion specific, potassium - Product Code JGS
Reason
This recall was initiated because beckman coulter has confirmed that for user-defined chemistries (udrs), the polychrome correction is not automatically updated when wavelengths are modified.
Action
The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased Synchron LX and UniCel¿¿ DxC Clinical Systems
Operating Software (all versions). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:
-After modifying any UDR wavelength, they MUST reboot to apply the update of the polychrome correction.
-If the modified UDR requires calibration, recalibrate after rebooting.
- Complete and return the enclosed RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd, PO Box 8000, Brea, California, 92282-8000; Mail Code E2.SE.08.
In addition, the customers were instructed to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If customers forwarded any of the affected product listed above to another laboratory, please provide a copy of this letter to them.
If customers have any questions regarding this Product Corrective Action letter, please call Beckman's Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada or www.beckmancoulter.com/customersupport/supportrequests.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
x-ray system. - Product Code IZI
Reason
A wire in the connector of the generator grid switch supervisor box might short-circuit between 12v power and ground, and it will cause a system breakdown.
Action
On 10/15/2010, Philips began sending out the URGENT-Device Correction Notice Failure Causing the Generator to Stop Working notification letter to their consignees.
The consignees were informed that a short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator, and it will cause the generator stops working. When the system fails during a critical interventional case, this may cause risk to patients (no Fluoro available).
The systems involved in this recall are Allura Xper with the Velara Generator, Allura Integris with OMCP Generator, MultiDiagnost Eleva, and OmniDiagnost Eleva Imaging system.
Consignees can contact Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 70800114, 70800115, 72200184, and 72200185.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
x-ray system - Product Code IZI
Reason
A wire in the connector of the generator grid switch supervisor box might short-circuit between 12v power and ground, and it will cause a system breakdown.
Action
On 10/15/2010, Philips began sending out the URGENT-Device Correction Notice Failure Causing the Generator to Stop Working notification letter to their consignees.
The consignees were informed that a short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator, and it will cause the generator stops working. When the system fails during a critical interventional case, this may cause risk to patients (no Fluoro available).
The systems involved in this recall are Allura Xper with the Velara Generator, Allura Integris with OMCP Generator, MultiDiagnost Eleva, and OmniDiagnost Eleva Imaging system.
Consignees can contact Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 70800114, 70800115, 72200184, and 72200185.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
x-ray system - Product Code IZI
Reason
A wire in the connector of the generator grid switch supervisor box might short-circuit between 12v power and ground, and it will cause a system breakdown.
Action
On 10/15/2010, Philips began sending out the URGENT-Device Correction Notice Failure Causing the Generator to Stop Working notification letter to their consignees.
The consignees were informed that a short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator, and it will cause the generator stops working. When the system fails during a critical interventional case, this may cause risk to patients (no Fluoro available).
The systems involved in this recall are Allura Xper with the Velara Generator, Allura Integris with OMCP Generator, MultiDiagnost Eleva, and OmniDiagnost Eleva Imaging system.
Consignees can contact Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 70800114, 70800115, 72200184, and 72200185.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
x-ray system - Product Code IZI
Reason
A wire in the connector of the generator grid switch supervisor box might short-circuit between 12v power and ground, and it will cause a system breakdown.
Action
On 10/15/2010, Philips began sending out the URGENT-Device Correction Notice Failure Causing the Generator to Stop Working notification letter to their consignees.
The consignees were informed that a short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator, and it will cause the generator stops working. When the system fails during a critical interventional case, this may cause risk to patients (no Fluoro available).
The systems involved in this recall are Allura Xper with the Velara Generator, Allura Integris with OMCP Generator, MultiDiagnost Eleva, and OmniDiagnost Eleva Imaging system.
Consignees can contact Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 70800114, 70800115, 72200184, and 72200185.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Thermal Regulating System - Product Code DWJ
Reason
The firm initiated this recall due to changes that have been made to the blanketrol iii model 233 device's operation and operation/technical service manuals, in order to stay in compliance with labeling regulations.
Action
On 10/18/2010 & 11/5/2010 the firm sent URGENT Medial Device Field Action letters, dated 10/18/2010, to their customers. The letters identified the affected product and stated the reason for recall. Customers were instructed to immediately collect and discard all affected product Operation and Operation/Technical Service manuals currently in their possession. They were to replace all the discarded manuals with the revised versions that were provided with the letter. The enclosed response form should be completed and returned by fax to 513-772-9119, scanned and e-mailed to B3manual@cszinc.com. If the product had been further distributed, then those customers should also be identified and notified of the field action via a copy of the letter. Customers should direct questions to the field action coordinator, David Niehaus at 513-773-8810 ext. 3234.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
ecg electrode - Product Code DRX
Reason
Poor signal or loss of signal. certain recalled devices have a loose wire attachment that may lead to intermittent or poor signal quality.
Action
ConMed Corporation distributed an Urgent Device Recall notification letter on Tru-Link ECG Electrode (Neonatal Pre-wired) dated September 23, 2010. ConMed Corp. has advised to cease the use of the devices immediately and conducted a recall to the user level. Direct consignees were asked to contact sub-accounts if recalled devices were further distributed and notified them of such recall. Recalled devices were to return to ConMed Corp. at 525 French Road, Utica, NY 13502 with completed Attachment II to indicate the amount returned. Customers with no recalled devices were asked to fill out Attachment II and faxed to 315-624-3225. Questions can be directed to Ms. Patricia Cotter, ConMed Recall Coordinator at 315-624-3237 or fax to 315-624-3225 or email to neorecall@conmed.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Monaco: in xio imrt (dynamic mlc delivery) software, the radiation beam angle is set to zero. if different beam angles are selected via monaco software, the beam angles will remain at zero.
Action
Computerized Medical Systems, Inc. sent a User Notice to the affected consignees on October 27, 2010, explaining the reason for correction, the clinical impact, and the workaround method. (VERIFY USE NOTICE DATE) A return postcard was included for the customer to confirm receipt of the User Notice. The firm intends for this issue to be corrected in Monaco Release 3.00 in March 2011.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Microtome, cryostat - Product Code IDP
Reason
Through internal quality review, firm determined the need to conduct a more comprehensive system validation to support the claim of complete bacterial, fungal and viral disinfection efficacy.
Action
ThermoFisher sent Advisory Notice letters beginning on September 28, 2010, to all affected customers. The letters stated that the firm needed to conduct more comprehensive system validation data on the Cold-Disinfection sytem option available on the HM550-D cryostat to support the claim of complete bacterial, fungal and viral disinfection efficacy. The letter recommended that the Cold Disinfection option on the HM550-D not be used as the sole disinfection method on the HM550-D until the validation work is completed. The firm provided addtional safety protocols pertaining to the cryostat disinfection. Customers were instructed to complete and fax the Confirmation of Receipt Form to Technical Support, COLD-D Advisory Notice at (269) 372-2436.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Extra notes in the data
infusion pump power cord - Product Code FRN
Reason
Complaints of broken, bent or missing prongs, charring, sparks, visible smoke, burnt smell have been reported on symbiq ac power cords.
Action
Hospira Recall notification letters were sent by Federal Express on November 1, 2010.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Medical charged-particle radiation therapy system. - Product Code IYE
Reason
If another patient is selected on the imaging system (xvi) release 4.5) during the transmission of end of treatment data from desktop pro r7.01 to r&v; system, the xvi information is prioritized and the end of treatment data is never received by the r&v; system.
Action
Important Notice A341 titled "Mandatory Upgrade Desktop Pro R7.01 Service Pack and Cancelled Notices" dated January 26, 2011, is in distribution to all affected customers. Field Change Order 20000501011, "Service Pack 2 upgrade to Desktop Pro R7.01 Service Pack 1", dated October 25, 2010 will be utilized by Elekta Service personnel to upgrade the Desktop Pro to include Service Pack 2. The Important Notice letter instructed customers to file the letter in the Important Notice section of the appropriate User Manual. Before doing so, users are to ensure that Desktop Pro R7.01 SP2 is installed on their treatment control system. If it is not installed, customers are to contact their local Elekta representative. Once the installation of Service Pack 2 has taken place, the notices listed in Table 1 of the letter will no longer be applicable and should be removed from the User Manual. Customers should direct their questions to their local Elekta representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
During an fda inspection on 10/1/2010 the firm was notified by fda that their field action they initiated in oct 2009, constituted a recall. the firm determined that the functional analysis feature in the comprehensive cardiac analysis (cca) was displaying incorrect values on the polar fields. the calculated results for the myocardial wall thickening was incorrect in that the numbers displayed f.
Action
Philips sent an URGENT - Field Safety Notice letter dated September 29, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to be aware that the numbers displayed for "Wall Thickening" actually represent a reduction in wall thickness from ES to ED.
Philips will be providing a sotware update to resolve the issue.
For further information or support customers were instructed to contact their local Philips representative:
Customer Care Service Center in the U.S. at 1-800-722-9377, option 5:
Diagnostic Imaging option 1: CT or their local Philips representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Microtome, cryostat - Product Code IDP
Reason
Through internal quality review, firm determined the need to conduct a more comprehensive system validation to support the claim of complete bacterial, fungal and viral disinfection efficacy.
Action
ThermoFisher sent Advisory Notice letters beginning on September 28, 2010, to all affected customers. The letters stated that the firm needed to conduct more comprehensive system validation data on the Cold-Disinfection sytem option available on the HM550-D cryostat to support the claim of complete bacterial, fungal and viral disinfection efficacy. The letter recommended that the Cold Disinfection option on the HM550-D not be used as the sole disinfection method on the HM550-D until the validation work is completed. The firm provided addtional safety protocols pertaining to the cryostat disinfection. Customers were instructed to complete and fax the Confirmation of Receipt Form to Technical Support, COLD-D Advisory Notice at (269) 372-2436.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Radioimmunoassay, dehydroepiandrosterone (free and sulfate) - Product Code JKC
Reason
The recall was initiated because beckman coulter has confirmed customer reports that dhea measurements using dhea ria (ref dsl-8900) kit lots identified may overstate actual dhea levels in patient samples.
Action
Beckman Coulter sent an "URGENT: PRODUCT CORRECTION ACTION" letter dated November 15, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.
The letter instructs customers to discontinue using the affected products and discard them according to local regulations. Customers were asked to review patient DHEA results ran on the affected lots and interpret them in light of additional tests (such as LH, FSH, testosterone, DHEA-S, cortisol,
17-hydroxyprogesterone, and estradiol) and the patient's clinical status. A response form was enclosed for customers to complete and return.
Contact the Beckman Coulter Technical Support Center at 1-800-854-3633 in the United States, or their local Beckman Coulter Representative for questions regarding this notification.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Surgical Camera and Accessories - Product Code KQM
Reason
If the vhm arm is left in the locked position, the gas spring can lose pressure and releasing the lock can result in a sudden downward movement.
Action
An Urgent Service Bulletin Notification was mailed to each ConMed Linvatec customer who received the affected product. The letter identified the affected product and stated the reason for notification. The letter asks customers to review the GCX Corporation Service Bulletins and updated Installation/User Manual. ConMed Linvatec recommends that customers periodically check the VHM Arm to see that it is functioning properly. In addition "Sudden Movement" stickers, provided by GCX, were also included to all consignees as part of the mailing. If customers in the US have questions or need technical support, they can contact ConMed Linvatec Endoscopy Customer Service at 888-292-0100 or e-mail Customerserv1@linvatec.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Counter, differential cell - Product Code GKZ
Reason
There is a possibility that a specimen could be diluted if a user requests diluent dispense while specimens are being automatically processed in cassette presentation. the dilution may cause erroneous results.
impact:
erroneous results from a diluted specimen could impact clinical decision making in cases such as blood transfusion, chemotherapy or antibiotic administration- particularly for popu.
Action
The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" (PCA) letter with PCA Response Form (via US Postal Service for US customers) dated October 20, 2010, to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter describes the product, problem and the following actions to be taken. The customers were instructed to remove all cassettes from the mix station prior to initiating the Diluent Dispense function to prevent the likelihood of a specimen being diluted; do not use pre-diluted samples for RETIC counts; verify that their information Technology personnel are aware that the Body Fluids data string is only transmitted to the LIS using the US numeric separators and the Body Fluid results are properly validated at the LIS. This will be corrected in a future version; use the lip on the reagent drawer as shown in the picture above; avoid touching the drawer slides while replacing containers; clean all spills promptly to reduce the risk of exposure to blood borne pathogens; complete and return enclosed PRODUCT CORRECTIVE ACTION RESPONSE FORM via fax to 786-639-7500/7501/7502/7503/7503/7504; mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06, 11800 S.W. 147th Avenue, PO Box 169015, Miami, FL 33116-9015 or email to: Regulatory.Notifications@beckmancoulter.com, and share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation.
If you have any questions regarding this PCA, contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees/customers local Beckman Coulter representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Counter, differential cell - Product Code GKZ
Reason
There is a possibility that a specimen could be diluted if a user requests diluent dispense while specimens are being automatically processed in cassette presentation. the dilution may cause erroneous results.
impact:
erroneous results from a diluted specimen could impact clinical decision making in cases such as blood transfusion, chemotherapy or antibiotic administration- particularly for popu.
Action
The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" (PCA) letter with PCA Response Form (via US Postal Service for US customers) dated October 20, 2010, to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter describes the product, problem and the following actions to be taken. The customers were instructed to remove all cassettes from the mix station prior to initiating the Diluent Dispense function to prevent the likelihood of a specimen being diluted; do not use pre-diluted samples for RETIC counts; verify that their information Technology personnel are aware that the Body Fluids data string is only transmitted to the LIS using the US numeric separators and the Body Fluid results are properly validated at the LIS. This will be corrected in a future version; use the lip on the reagent drawer as shown in the picture above; avoid touching the drawer slides while replacing containers; clean all spills promptly to reduce the risk of exposure to blood borne pathogens; complete and return enclosed PRODUCT CORRECTIVE ACTION RESPONSE FORM via fax to 786-639-7500/7501/7502/7503/7503/7504; mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06, 11800 S.W. 147th Avenue, PO Box 169015, Miami, FL 33116-9015 or email to: Regulatory.Notifications@beckmancoulter.com, and share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation.
If you have any questions regarding this PCA, contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees/customers local Beckman Coulter representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Catheter, infusion - Product Code JCY
Reason
On 09/13/2010 conmed linvatec, largo, fl initiated a recall on 24k100 arthroscopy outflow/suction tube set used with the conmed linvatec 24k pump. the 24k100 arthroscopy outflow/suction tubing set lots 22747-000, 22748-000, and 2749-000 may have been incorrectly assembled and could potentially allow waste to enter the sterile field.
Action
Linvatec Corp. dba ConMed Linvatec sent an Urgent Medical Device Recall Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to immediately check their facility's inventory for the affected product. If they had any of the product they were instructed not to use and segregate the product and return for credit.
Return the affected products and the completed REPLY FORM to their local ConMed Linvatec office.
If the product was transferred to another facility, customers were instructed to complete the REPLY FORM documenting the transfer of the product and mail or fax the REPLY FORM to their local ConMed Linvatec office at 727-319-5701.
If the customers do not have the affected product they should complete the REPLY FORM and mail in the enclosed envelope or fax to 727-319-5701.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Xio: when the beam template is recalled, xio prematurely initiates a dose calculation, re-snaps the mlc or port to the structure of the current patient , but then fails to re-calculate dose for the new mlc or port position. if no subsequent change is made to force a dose recalculation, xio will display the dose from the original mlc/port shape dose instead of the dose from the re-snapped mlc/port.
Action
The firm, Elekta CMS Software, sent an "IMPORTANT SAFETY NOTICE" dated September 14, 2010 to its affected customers. The notice describes the product, problem and actions to be taken. The customers were instructed to distribute this notice to any all users of CMS software at their organization who are potentially affected by this issue, and complete and return the attached postcard to confirm receipt of the Safety Notice.
The notice also states that this problem has existed since the XiO Release 4.3.0 and is resolved in the XiO release 4.26.00. Elekta will notify the customers when this solution is available.
If you have any questions, please call 314-993-0003 or toll free 800-878-4267.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
When a dialog box is displayed and the dose status is changed to "dose not current", beam edits can be made in the graphics area using the mouse (rotate collimator, reposition collimator, move isocenter, move weight point, etc.). then if cancel is selected on the dialog box, any edits made on the dialog box are undone, the dose is left unchanged, but the beam edits made in the graphics area with t.
Action
The firm, Elekta CMS Software, sent an "IMPORTANT SAFETY NOTICE" dated September 6, 2010 to its affected customers. The notice describes the product, problem and actions to be taken (workaround). The customers were instructed to distribute this notice to any and all users of CMS software at their organization who are potentially affected by this issue.
The notice also states that this problem has existed since XiO Release 4.2.0 and will be resolved in XiO Release 4.70.00. Elekta will notify the sites when this solution is available.
If you have any questions, please call 314-993-0003 or Toll Free: 800-878-4267.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
When rt plans are exported from xio and rt structure sets and images are exported from monaco, the dicom iso-center coordinates may not be accurate.
Action
Elekta / Computerized Medical Systems Inc began mailing an Important Safety Notice to all affected customers in September 2010. The notice identified the product, the problem, and the action to be taken by the customer. Customers were advised not to mix treatment plan information from multiple planning systems. Customers were asked to return the postcard as proof of receipt and their understanding of the Safety Notice.
For questions regarding this recall call 408-830-8000.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Counter, differential cell - Product Code GKZ
Reason
For panels containing cbc: the rbc and hct are improperly corrected and not flagged when there is a wbc pump failure and the wbc ~ 140x103/ul.
for body fluid panels:
the rbc is improperly corrected and not flagged when there is a wbc pump failure.
impact:
erroneous rbc and/or hct could affect the interpretation and management of patients at risk with various types of anemias.
Action
The recall communication was initiated on 10/20/2010, with Beckman Coulter forwarding a Product Corrective Action (PCA) letter with PCA Response Form (via US Postal Service for US customers) to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter informs the customers about the problems identified and provides an action/resolution to this issue.
When a WBC Pump Failure occurs, the WBC or TNC results will be flagged with 'R' and the WBC Pump Failure System message. The RBC and/or HCT results associated with these affected analyses also require review. This will be corrected in a future version of software.
Beckman Coulter asked consignees to complete and return the enclosed response form within 10 days and share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation.
Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees local Beckman Coulter representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Counter, differential cell - Product Code GKZ
Reason
Retic results may be invalid when the instrument user interface allows reflex processing of a pre-diluted specimen in the retic test panel. beckman coulter has validated pre-diluted specimen processing in cbc panels. retic test panel using pre-diluted samples has not been validated.
impact:
the reticulocyte value is an indicator for assessing red cell production. erroneous results could impact c.
Action
The firm, Beckman Coulter, issued an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010, with PCA Response Form to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter described the product, problem and actions to be taken. The customers were instructed to do the following:
1) Remove all cassettes from the mix station prior to initiating the Diluent Dispense function. Do not initiate Diluent Dispense while specimens are being processed in cassette presentation.
2)Do not use pre-diluted samples for RETIC counts. The instrument is validated for pre-diluted CBC's only, as indicated in the Instructions for Use (IFU).
3)Verify that their information Technology personnel are aware that the Body Fluids data string is only transmitted to the LIS using the US numeric separators and that the Body Fluid results are properly validated at the LIS.
4) Use the lip on the reagent drawer to move the drawer as shown. Avoid touching the drawer slides while replacing containers. Clean all spills promptly to reduce the risk of exposure to blood borne pathogens.
5)Complete and return the enclosed PRODUCT CORRECTIVE RESPONSE FORM within 10 days, share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation.
Beckman Coulter will make corrections in future version software.
Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees/customers local Beckman Coulter representative.