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
Enzyme immunoassay, gentamicin - Product Code LCD
Reason
The reagent produces false low test results. beckman coulter has confirmed low recovery of values at the low end of the therapeutic range (<1.5 ug/ml, <3.13 umol/l) with synchron systems gentamicin reagent (gen) lot m804552. a false low result can cause a patient to receive more medication than necessary.
Action
Beckman Coulter sent an Urgent Product Corrective Action (PCA) letter dated February 27, 2009 to customers identifying the affected product and issue prompting the recall. The letter asked them to discontinue use and discard the reagent lot, and contact their Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada or contact their local Beckman Coulter Representative to discuss reagent replacement options. They were also asked to complete and return the enclosed response form within 10 days.
Customers were directed to call the Customer Support Center (Hotline) at (800) 854-3633 in the US and Canada if they had questions in regards to the PCA letter. Outside the US and Canada they were told to contact their 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
radiation therapy treatment planning system - Product Code MUJ
Reason
Software issue/mistreatment potential-- due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered.
Action
Varian Medical Systems Recall initiated on July 17, 2009. A product notification letter was distributed to the affected user, with a description of the problem and user corrective action steps. The letter will be distributed to the sales, marketing and service organizations via certified mail. A software correction is planned.
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, human chorionic gonadotropin - Product Code JHI
Reason
The recall was initiated because beckman coulter has confirmed that certain access total ¿hcg reagent packs show decreased stability from the date of manufacture, which may lead to increased imprecision.
Action
The recall communication was initiated on March 18, 2009 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter dated March 13, 2009 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access Immunoassay Systems total ¿hCG. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discontinue use of the reagent lot numbers 824542 and 825652, and discard any unused reagent packs.
Customers were asked to review their historical records for low level quality control to ensure that the assay performance for the referenced lot numbers has been within their laboratory specifications. They were also asked to share the information with their laboratory staff and retain the letter for their Quality System documentation, and then complete and return the enclosed response form within 10 days so that they may be assured that consignees received the notification.
Finally they were told to contact Customer Technical Support Center at 1-800-854-3633 in the US and Canada, or their local Beckman Coulter Representative with any questions.
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
Powered Radiation Therapy Couch - Product Code JAI
Reason
Mechanical failure-- patient support system's table top may unexpectedly descend several inches.
Action
Consignees were notified verbally about the issue when an inspection was scheduled.
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, continuous flush - Product Code KRA
Reason
Sterility loss-- the sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection.
Action
Boston Scientific issued an Urgent Medical Device Recall letter dated August 26, 2009 identifying the affected devices, the issue prompting the recall, and actions to be taken by customers.
Customers were instructed to determine if they have affected product in their inventory, and if so, immediately quarantine and return to Boston Scientific.
Customers can contact Boston Scientific at 510 624-1734.
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, continuous flush - Product Code KRA
Reason
Sterility loss-- the sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection.
Action
Boston Scientific issued an Urgent Medical Device Recall letter dated August 26, 2009 identifying the affected devices, the issue prompting the recall, and actions to be taken by customers.
Customers were instructed to determine if they have affected product in their inventory, and if so, immediately quarantine and return to Boston Scientific.
Customers can contact Boston Scientific at 510 624-1734.
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.
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
Enzymatic method, ammonia - Product Code JIF
Reason
The ammonia reagent lot m808278 may fail calibration or cause a low shift in quality control recovery on some synchron systems.
Action
Beckman Coulter mailed a Product Corrective Action (PCA) Letter on April 13, 2009 dated April 10, 2009 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers to discontinue use and discard appropriately the lot number(s) of the affected product and contact their Customer Service Representative at (800) 526-3821 (US), or (800)463-7828 for reagent replacement. Customers were instructed to complete and return the enclosed response form within 10 days so that Beckman Coulter may maintain records.
Customers were told to call the Customer Support Center (Hotline) at (800) 854-3633 with any questions regarding the PCA letter.
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
Ultrasonic Pulsed Echo Imaging System - Product Code IYO
Reason
Mistreatment risk-- when a user defined formula is used to calculate a value in a vascular exam, data is switched laterally when it is internally transferred and displayed on the summary report within the system.
Action
A field correction was initiated and a Customer Safety Advisory Notification was sent out on 7/29/09. The letter identified the affected product and stated that there was a potential for user defined calculations to be incorrect within the vascular package when using the listed software versions of the product. The letter also discussed the steps that customers could take to avoid the potential risk of the issue. A mandatory update software was developed and will be installed free of charge. Customers should have been contacted to schedule a time for the installation. Questions were to be directed to the local service support person.
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.
Product failure-- when the 64-channel system v5m is used in the 128-channel mode, an over current fault occurs which shuts the system down.
Action
Siemens sent a Customer Safety Advisory Notification letter on July 24, 2009. The letter identified the product, the problem, and the action to be taken by the customer. A software update will be conducted in the field. Until that update occurs, customers were instructed to image without the CW doppler to avoid a system shut down.
Customers were instructed to contact their service support person with any questions.
For questions regarding this recall call 650-694-5993.
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
Accelerator, linear, medical - Product Code IYE
Reason
Potential for mistreatment-- when treatment plans intended for non-artiste machinese are loaded, if the plans contain unspecified beam parameters, attributes or unknown block codes, the therapy system may remove those parameters.
Action
The firm,Siemens, sent two Customer Advisory letters (TH004/09/S and TH008/09/S) contained in the Update Instructions to all consignees/customers with active devices. The letters describe the product, problem and action to be taken by the customers. The customers were instructed to follow the updated instructions. Siemens service representative will sign a document noted as CORRECTED upon completion of the software installation.
If you have any questions, call 1-925-602-8157.
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
System, x-ray, tomography, computed - Product Code JAK
Reason
1. it has been found that in raw data processing for go&return; helical scanning, when the raw data acquired in the first scan (go) and that acquired in the second scan (return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by return scanning, while all related information is displayed on the reco.
Action
The firm, Toshiba America Medical Systems, Inc., sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated July 30, 2009 to its Consignees/customers. The letter described the product, problem and actions to be taken. The letter informed them of the above mentioned reason for recall and telling them that a corrective measure will be installed to prevent the occurrence of the above problems. They were told that their Toshiba service representative will contact them to install the measures.
Furthermore Toshiba instructed them to adopt the following temporary measures to avoid these phenomena until corrective measures have been taken.
1. When performing raw data processing for Go&Return; helical scan, select the raw data acquired for Go and that acquired for Return separately in order to perform reconstruction
2. When using the Sure Exposure 3D function, confirm that the error message shown in the preceding page is not displayed on the monitor at the time of setup (until the Scan Start button lights after the Confirm button is clicked).
3. When executing an eXam Plan in which Sure Exposure 3D is selected as the actual scan for Sure Start, confirm that the error message show in the preceding page is not displayed on the monitor when monitoring scan is switched to the actual scan. If the error message is displayed, click [OK] in the error message dialog to continue processing.
The letter should be shared with facility's Biomedical or Clinical Engineering Department. Also the customers were instructed to complete and return the Customer Reply Form via fax to: Regulatory Affairs at 877-349-3054.
If you have any questions regarding this letter, contact Director, Regulatory Affairs at (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968 with any questions regarding the letter.
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.
Pediatric trachel tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway.
Action
Smiths Medical issued an "Urgent Field Safety Notice" dated August 24, 2009 via UPS Second Day Mail including a Guidance Chart. Return of the enclosed Confirmation Form was also requested by fax to 1-603-355-8157. Smiths Medical issued a revised recall letter dated September 9, 2009. Customers are requested to return unused affected product to the firm.
For further information, contact Smiths Medical ASD, Inc. by phone at 1-800-348-6064, prompt 4 extension 2273.
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.
Pediatric trachel tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway.
Action
Smiths Medical issued an "Urgent Field Safety Notice" dated August 24, 2009 via UPS Second Day Mail including a Guidance Chart. Return of the enclosed Confirmation Form was also requested by fax to 1-603-355-8157. Smiths Medical issued a revised recall letter dated September 9, 2009. Customers are requested to return unused affected product to the firm.
For further information, contact Smiths Medical ASD, Inc. by phone at 1-800-348-6064, prompt 4 extension 2273.
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.
Pediatric trachel tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway.
Action
Smiths Medical issued an "Urgent Field Safety Notice" dated August 24, 2009 via UPS Second Day Mail including a Guidance Chart. Return of the enclosed Confirmation Form was also requested by fax to 1-603-355-8157. Smiths Medical issued a revised recall letter dated September 9, 2009. Customers are requested to return unused affected product to the firm.
For further information, contact Smiths Medical ASD, Inc. by phone at 1-800-348-6064, prompt 4 extension 2273.
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.
Pediatric trachel tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway.
Action
Smiths Medical issued an "Urgent Field Safety Notice" dated August 24, 2009 via UPS Second Day Mail including a Guidance Chart. Return of the enclosed Confirmation Form was also requested by fax to 1-603-355-8157. Smiths Medical issued a revised recall letter dated September 9, 2009. Customers are requested to return unused affected product to the firm.
For further information, contact Smiths Medical ASD, Inc. by phone at 1-800-348-6064, prompt 4 extension 2273.
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.
Pediatric trachel tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway.
Action
Smiths Medical issued an "Urgent Field Safety Notice" dated August 24, 2009 via UPS Second Day Mail including a Guidance Chart. Return of the enclosed Confirmation Form was also requested by fax to 1-603-355-8157. Smiths Medical issued a revised recall letter dated September 9, 2009. Customers are requested to return unused affected product to the firm.
For further information, contact Smiths Medical ASD, Inc. by phone at 1-800-348-6064, prompt 4 extension 2273.
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.
Pediatric trachel tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway.
Action
Smiths Medical issued an "Urgent Field Safety Notice" dated August 24, 2009 via UPS Second Day Mail including a Guidance Chart. Return of the enclosed Confirmation Form was also requested by fax to 1-603-355-8157. Smiths Medical issued a revised recall letter dated September 9, 2009. Customers are requested to return unused affected product to the firm.
For further information, contact Smiths Medical ASD, Inc. by phone at 1-800-348-6064, prompt 4 extension 2273.
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.
Pediatric trachel tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway.
Action
Smiths Medical issued an "Urgent Field Safety Notice" dated August 24, 2009 via UPS Second Day Mail including a Guidance Chart. Return of the enclosed Confirmation Form was also requested by fax to 1-603-355-8157. Smiths Medical issued a revised recall letter dated September 9, 2009. Customers are requested to return unused affected product to the firm.
For further information, contact Smiths Medical ASD, Inc. by phone at 1-800-348-6064, prompt 4 extension 2273.
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.
Pediatric trachel tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway.
Action
Smiths Medical issued an "Urgent Field Safety Notice" dated August 24, 2009 via UPS Second Day Mail including a Guidance Chart. Return of the enclosed Confirmation Form was also requested by fax to 1-603-355-8157. Smiths Medical issued a revised recall letter dated September 9, 2009. Customers are requested to return unused affected product to the firm.
For further information, contact Smiths Medical ASD, Inc. by phone at 1-800-348-6064, prompt 4 extension 2273.
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.
Pediatric trachel tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway.
Action
Smiths Medical issued an "Urgent Field Safety Notice" dated August 24, 2009 via UPS Second Day Mail including a Guidance Chart. Return of the enclosed Confirmation Form was also requested by fax to 1-603-355-8157. Smiths Medical issued a revised recall letter dated September 9, 2009. Customers are requested to return unused affected product to the firm.
For further information, contact Smiths Medical ASD, Inc. by phone at 1-800-348-6064, prompt 4 extension 2273.
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.
Pediatric trachel tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway.
Action
Smiths Medical issued an "Urgent Field Safety Notice" dated August 24, 2009 via UPS Second Day Mail including a Guidance Chart. Return of the enclosed Confirmation Form was also requested by fax to 1-603-355-8157. Smiths Medical issued a revised recall letter dated September 9, 2009. Customers are requested to return unused affected product to the firm.
For further information, contact Smiths Medical ASD, Inc. by phone at 1-800-348-6064, prompt 4 extension 2273.
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.
Pediatric trachel tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway.
Action
Smiths Medical issued an "Urgent Field Safety Notice" dated August 24, 2009 via UPS Second Day Mail including a Guidance Chart. Return of the enclosed Confirmation Form was also requested by fax to 1-603-355-8157. Smiths Medical issued a revised recall letter dated September 9, 2009. Customers are requested to return unused affected product to the firm.
For further information, contact Smiths Medical ASD, Inc. by phone at 1-800-348-6064, prompt 4 extension 2273.
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.
Pediatric trachel tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway.
Action
Smiths Medical issued an "Urgent Field Safety Notice" dated August 24, 2009 via UPS Second Day Mail including a Guidance Chart. Return of the enclosed Confirmation Form was also requested by fax to 1-603-355-8157. Smiths Medical issued a revised recall letter dated September 9, 2009. Customers are requested to return unused affected product to the firm.
For further information, contact Smiths Medical ASD, Inc. by phone at 1-800-348-6064, prompt 4 extension 2273.
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
nerve stimulator - Product Code LYJ
Reason
Some vns therapy system replacement demipulse generators reporting low lead impedance readings. in rare instances, a system diagnostic test using model 250 programming software (versions 7.1 and earlier) may report "lead impedance: ok" when a short-circuit condition exists.
Action
Cyberonics sent an Important Safety Notice on July 24, 2009, to all physicians explaining the event, risks presented and recommended actions to take. Labeling updates are being developed concurrently with the notification. The firm will mail or hand-deliver the notifications via firm representatives.