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
Due to software issue, an error occurs when performing cone planning using mri, which may result in the patient receiving a higher radiation dose than expected, potentially to healthy tissue.
Action
Varian sent Urgent Medical Device Correction letters on March 23, 2010, by Federal Express to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to run test cases or otherwise determine whether the MR images that they receive have the 'Series Date' parameter populated.
Customers should contact their MR system manufacturer to get a confirmation that the 'Series Date' field is populated.
Customers were instructed to confirm by visual inspection that the fusion results are loaded appropriately in Cone Planning before starting to create or edit a plan.
For questions regarding this recall contact your local Varian Customer Support Distirct or Regional Manager.
Phone: USA and Canada - 1-888-VARIANS (888-827-4265)
Europe -+41 41 749 8844
E-mail: North America: support-america@varian.com
Australia/New Zealand: support-anz@varian.com
Europe: support-emea@varian.com
South East Asia: seasia.apps.helpdesk@varian.com
China/Asia: china.apps.helpdesk@varian.com
Japan: Japan.Apps.Helpdesk@varian.com
Latin America: soporte.al@varian.com
Internet: Oncology Systems customer site - www.myvarian.com
Varian Medical System public site - www.varian.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.
Firm discovered that some of their straight broach handles are experiencing early failure due to a weakened handle locking mechanism (leaf spring).
Action
On June 3, 2010, an "Alert: Femoral Broach Handle Repair" went out to the entire sales force/customers via "Sales Mail" and posted to the DePuy Internal website. The Alert stated that "We have discovered that some of our straight broach handles are experiencing early failure due to a weakened handle locking mechanism (Leaf Spring).
As you perform routine maintenance on your sets, if you have any of these broaches stamped with the lot numbers listed, it is recommended you have them sent in to be reworked with a new spring device."
Send the broach handles to:
DePuy Orthopaedics
Attn: Repairs
700 Orthopaedic Dr
Warsaw, IN 46581
Please include return shipping information
If you have any questions regarding this information or need additional information, call 574-372-7333.
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.
Medtronic is informing you of a rare device software issue in certain icd and crt-d devices. a software update will be available to correct his issue. there have been 5 reports of this issue occurring with no reported patient injuries or deaths. medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. in the u.
Action
Medtronic, Inc. sent an IMPORTANT MEDICAL DEVICE CORRECTION LETTER, dated May 2010 to physicians beginning May 05, 2010. The letter informed doctors of the issue and informed them that a software update would be available to correct this issue. The software was to be installed on the programmer, with a Medtronic representatives assistance, so that on a patient's next in-clinic interrogation the device would receive the upgrade automatically and their device would be corrected.
For any questions regarding this recall physicians were to contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636.
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.
Medtronic is informing you of a rare device software issue in certain icd and crt-d devices. a software update will be available to correct his issue. there have been 5 reports of this issue occurring with no reported patient injuries or deaths. medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. in the u.
Action
Medtronic, Inc. sent an IMPORTANT MEDICAL DEVICE CORRECTION LETTER, dated May 2010 to physicians beginning May 05, 2010. The letter informed doctors of the issue and informed them that a software update would be available to correct this issue. The software was to be installed on the programmer, with a Medtronic representatives assistance, so that on a patient's next in-clinic interrogation the device would receive the upgrade automatically and their device would be corrected.
For any questions regarding this recall physicians were to contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636.
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 device, for ablation of cardiac tissue - Product Code OCL
Reason
Sterility compromised-- the sterile pouch in which the product is packaged may be compromised, which could result in patient infection.
Action
Cardima issued a Product Recall Notification dated May 18, 2010 to customers, identifying the affected product, the sterility issue, and the actions to be taken by the customer. Custormers are to quarantine and return the affected product to the firm. The firm will replace returned product as soon as it becomes available.
Cardima Customer Service can be contacted at 800 354-0102.
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.
The firm received a complaint regarding the plastic housing used to support the trapeze handle. the firm investigated and found that the manufacturer of the trapeze handle didn't correctly process the plastic component. therefore the plastic had the potential to break prematurely.
Action
The firm, Hill-Rom, sent an "Urgent Field Safety Notice" letter dated June 11, 2010, to its customers. The letter describes the product, problem and action to be taken by the customers. Hill-Rom provided the quantity of handles needed to replace handles customers received during the affected period. The customers were instructed to immediately remove and replace all Trapeze Handles that were delivered during the affected period; to replace the Trapeze Handle Assemblies (with a manufacturing date from January 2007 to January 2009) used on their Patient Helper with the enclosed unit(s); complete and return the Customer Response Form as soon as possible, or by July 26, 2010; advise the firm immediately if they have relocated the beds and/or the accessories to another location, and forward the letter to any other facility personnel they deem appropriate.
If you have any questions concerning this request or the procedure as outlined, please contact Hill-Rom Technical Support at 800-445-3720.
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.
Medtronic is informing you of a rare device software issue in certain icd and crt-d devices. a software update will be available to correct his issue. there have been 5 reports of this issue occurring with no reported patient injuries or deaths. medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. in the u.
Action
Medtronic, Inc. sent an IMPORTANT MEDICAL DEVICE CORRECTION LETTER, dated May 2010 to physicians beginning May 05, 2010. The letter informed doctors of the issue and informed them that a software update would be available to correct this issue. The software was to be installed on the programmer, with a Medtronic representatives assistance, so that on a patient's next in-clinic interrogation the device would receive the upgrade automatically and their device would be corrected.
For any questions regarding this recall physicians were to contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636.
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.
Medtronic is informing you of a rare device software issue in certain icd and crt-d devices. a software update will be available to correct his issue. there have been 5 reports of this issue occurring with no reported patient injuries or deaths. medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. in the u.
Action
Medtronic, Inc. sent an IMPORTANT MEDICAL DEVICE CORRECTION LETTER, dated May 2010 to physicians beginning May 05, 2010. The letter informed doctors of the issue and informed them that a software update would be available to correct this issue. The software was to be installed on the programmer, with a Medtronic representatives assistance, so that on a patient's next in-clinic interrogation the device would receive the upgrade automatically and their device would be corrected.
For any questions regarding this recall physicians were to contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636.
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 Maggots - Product Code NQK
Reason
Monarch labs initiated the field notification regarding their medical maggots from batch mm090406 with the accessory leflap dressing due a customer complaint from a physician of a patient developing cellulitis after using maggots from the affected batch.
Action
The customer recall communication was initiated on May 3, 2009 with Monarch Labs notifying all consignees with a via a faxed Recall Letter with fax-back attachment of the initial compliant they had received and the possible infection that may occur if instructions for use are not followed.
All therapists, who used maggots from that batch were instructed to contact the firm immediately if they have experienced any adverse events, such as infection, cellulitis, or any other problem. If not, they were asked to simply return the fax-back attachment , noting "no problem" .
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
Antinuclear antibody, antigen, control - Product Code LKJ
Reason
The ana screening kit generates a high percentage of false positive results, associated with a low check control reading.
Action
Bio-Rad issued an Urgent Medical Device Recall Notification letter dated March 1, 2010 to customers describing the issue and actions to be taken. Responses will be tracked via response forms. The letter instructed customers that affected products should be identified, quarantined, and discarded, or reworked with shorter expiration dates until newer lots are available.
Bio-Rad can be contacted at 510-724-7000 concerning this recall.
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.
Medtronic is informing you of a rare device software issue in certain icd and crt-d devices. a software update will be available to correct his issue. there have been 5 reports of this issue occurring with no reported patient injuries or deaths. medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. in the u.
Action
Medtronic, Inc. sent an IMPORTANT MEDICAL DEVICE CORRECTION LETTER, dated May 2010 to physicians beginning May 05, 2010. The letter informed doctors of the issue and informed them that a software update would be available to correct this issue. The software was to be installed on the programmer, with a Medtronic representatives assistance, so that on a patient's next in-clinic interrogation the device would receive the upgrade automatically and their device would be corrected.
For any questions regarding this recall physicians were to contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636.
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
Cardiovascular Procedure Kit - Product Code DTR
Reason
Vent port may be occluded and prevent delivery of fluid.
Action
Terumo, Ashland, MA notified consignees on 6/8/10, by
phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight
mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction
activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
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
Anti-dna antibody (enzyme-labeled), antigen, control - Product Code LRM
Reason
The firm received customer complaints of increased positivity rates associated with the anti-dsdna test kits.
Action
The firm, Bio-Rad, sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated March 2, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and quarantine the affected kit lots; discard all affected product in accordance with all local, state and federal disposal procedures; complete and return the enclosed MEDICAL DEVICE RECALL RESPONSE FORM via fax to: (510) 741-3954, attn: Bio-Rad CSD Regulatory Affairs Department, and to please re-evaluate all positive patient samples and retest if necessary.
If you have any questions, contact Bio-Rad CSD Regulatory Affairs Department at 510-724-7000.
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
Anti-dna antibody (enzyme-labeled), antigen, control - Product Code LRM
Reason
The firm received customer complaints of increased positivity rates associated with the anti-dsdna test kits.
Action
The firm, Bio-Rad, sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated March 2, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and quarantine the affected kit lots; discard all affected product in accordance with all local, state and federal disposal procedures; complete and return the enclosed MEDICAL DEVICE RECALL RESPONSE FORM via fax to: (510) 741-3954, attn: Bio-Rad CSD Regulatory Affairs Department, and to please re-evaluate all positive patient samples and retest if necessary.
If you have any questions, contact Bio-Rad CSD Regulatory Affairs Department at 510-724-7000.
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
Cardiovascular Procedure Kit - Product Code DTR
Reason
Vent port may be occluded and prevent delivery of fluid.
Action
Terumo, Ashland, MA notified consignees on 6/8/10, by
phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight
mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction
activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
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
Cardiovascular Procedure Kit - Product Code DTR
Reason
Vent port may be occluded and prevent delivery of fluid.
Action
Terumo, Ashland, MA notified consignees on 6/8/10, by
phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight
mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction
activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
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
Cardiovascular Procedure Kit - Product Code DTR
Reason
Vent port may be occluded and prevent delivery of fluid.
Action
Terumo, Ashland, MA notified consignees on 6/8/10, by
phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight
mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction
activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
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
Cardiovascular Procedure Kit - Product Code DTR
Reason
Vent port may be occluded and prevent delivery of fluid.
Action
Terumo, Ashland, MA notified consignees on 6/8/10, by
phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight
mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction
activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
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
Cardiovascular Procedure Kit - Product Code DTR
Reason
Vent port may be occluded and prevent delivery of fluid.
Action
Terumo, Ashland, MA notified consignees on 6/8/10, by
phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight
mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction
activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
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
Cardiovascular Procedure Kit - Product Code DTR
Reason
Vent port may be occluded and prevent delivery of fluid.
Action
Terumo, Ashland, MA notified consignees on 6/8/10, by
phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight
mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction
activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
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
Cardiovascular Procedure Kit - Product Code DTR
Reason
Vent port may be occluded and prevent delivery of fluid.
Action
Terumo, Ashland, MA notified consignees on 6/8/10, by
phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight
mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction
activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
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
Cardiovascular Procedure Kit - Product Code DTR
Reason
Vent port may be occluded and prevent delivery of fluid.
Action
Terumo, Ashland, MA notified consignees on 6/8/10, by
phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight
mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction
activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
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
Cardiovascular Procedure Kit - Product Code DTR
Reason
Vent port may be occluded and prevent delivery of fluid.
Action
Terumo, Ashland, MA notified consignees on 6/8/10, by
phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight
mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction
activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
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
Cardiovascular Procedure Kit - Product Code DTR
Reason
Vent port may be occluded and prevent delivery of fluid.
Action
Terumo, Ashland, MA notified consignees on 6/8/10, by
phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight
mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction
activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
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
Cardiovascular Procedure Kit - Product Code DTR
Reason
Vent port may be occluded and prevent delivery of fluid.
Action
Terumo, Ashland, MA notified consignees on 6/8/10, by
phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight
mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction
activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.