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.
Notas adicionales en la data
Magnetic resonance diagnostic device - Product Code LNH
Causa
If the lateral table adjustment crank handle breaks off, it has sufficient attractive force to the magnet and may result in patient injury.
Acción
Consignees were sent on 8/23/10 a GE "Urgent Medical Device Correction" letter dated August 20, 2010. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Customers were asked to discontinue use of their MR system and to contact their local service representative, if the lateral table adjustment crank handle on the table becomes loose.
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.
Notas adicionales en la data
Magnetic resonance diagnostic device - Product Code LNH
Causa
If the lateral table adjustment crank handle breaks off, it has sufficient attractive force to the magnet and may result in patient injury.
Acción
Consignees were sent on 8/23/10 a GE "Urgent Medical Device Correction" letter dated August 20, 2010. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Customers were asked to discontinue use of their MR system and to contact their local service representative, if the lateral table adjustment crank handle on the table becomes loose.
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.
Notas adicionales en la data
Antinuclear Antibody, Antigen Control - Product Code LKJ
Causa
The firm received customer complaints of increased positivity rates associated with the ana screening kit due to a decline in stability.
Acción
An Urgent: Medical Device Recall Notification, dated March 1, 2010, was provided to the firm's consignee, identifying the affected product and stating the reason for the recall. The letter also asked the customer to examine their inventory and quarantine the affected kits. If the product had been further distributed, those customers must be identified, notified, and asked to discontinue use of the affected product. Customers were to discard all affected product and complete and return the enclosed Medical Device Recall Response Form. The letter also stated that replacement kits would be available in mid-March.
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.
Notas adicionales en la data
Antinuclear antibody, antigen, control - Product Code LKJ
Causa
False positive test results caused by decrease in the od values of ana cutoff controls and ana positive controls. the increased positivity rates were associated with the meridian ana screening kit. false positive ana values could result in misdiagnosis or mistreatment .
Acción
Bio-Rad issued an Urgent Medical Device Recall NOtification letter dated February 24, 2010 to their distributor, identifying the affected product and actions to be taken. The distributor was instructed to examine inventory and quarantive affected kit lots, and to identify and notify customers with affected lots to discontinue use and discard the product. Replacement kits will be distributed. Customers were asked to complete and return a recall response form.
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.
Zimmer, inc. has determined that there is a potential for a package to be labeled as a 28 mm femoral
head but contain a 32 mm femoral head. in addition, there is a potential for the patient record label to
be incorrect.
Acción
The firm, Zimmer, Inc., sent an "URGENT: DEVICE REMOVAL" letter dated July 9, 2010, to all consignees. The letter described the issue, clinical implications, affected product, and required actions. The consignees were instructed to carefully review the letter, ensure users of the VerSys Hip System Femoral Head device at their faculty have been informed of this removal and perform a physical count of all affected product at their facility, record the data on the Inventory Return Certification Form and/or the User Facility/HCP Form and return the form via fax at (574) 372-4265 or email: aimee.wood@zimmer.com. Zimmer Inc. will conduct a removal of all remaining (unused) units of the subject lots.
For shipping assistance, questions or assistance in notifying your accounts about the device removal, please contact Zimmer, Inc. at 1-800-613-6131 or 574-372-4463.
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.
Notas adicionales en la data
Wire, guide, catheter - Product Code DQX
Causa
The guidewire has the potential to flake off polytetrafluroethylene (ptfe) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system.
Acción
Boston Scientific Corporation sent an Urgent Medical Device Recall letter dated June 7, 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 immediately discontinue use of and segregate the affected product.
Complete and return the Reply Verification Tracking Form even if they did not have any affected product.
Contact the Customer Service Call Center to obtain a Returned Goods Authorization (RGA) Number at (800) 811-3211, Option #1.
E-mail or Fax the completed and signed Reply Verification Tracking Form to
email Bob.Ware@bsci.com or the Field Action Fax (510) 624-2475.
PackageShip and return the affected product along with the original Reply Verification Tracking Form by Federal Express to:
Boston Scientific Corporation
US Distribution Center
Boston Scientific Marina Bay
Customer Fulfillment Center
500 Commander Shea Blvd.
Quincy, Massachusetts 02171
RGA: ____________
For questions regarding this recall call (510) 624-2563.
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.
Notas adicionales en la data
Wire, guide, catheter - Product Code DQX
Causa
The guidewire has the potential to flake off polytetrafluroethylene (ptfe) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system.
Acción
Boston Scientific Corporation sent an Urgent Medical Device Recall letter dated June 7, 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 immediately discontinue use of and segregate the affected product.
Complete and return the Reply Verification Tracking Form even if they did not have any affected product.
Contact the Customer Service Call Center to obtain a Returned Goods Authorization (RGA) Number at (800) 811-3211, Option #1.
E-mail or Fax the completed and signed Reply Verification Tracking Form to
email Bob.Ware@bsci.com or the Field Action Fax (510) 624-2475.
PackageShip and return the affected product along with the original Reply Verification Tracking Form by Federal Express to:
Boston Scientific Corporation
US Distribution Center
Boston Scientific Marina Bay
Customer Fulfillment Center
500 Commander Shea Blvd.
Quincy, Massachusetts 02171
RGA: ____________
For questions regarding this recall call (510) 624-2563.
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 evolis assay protocol files software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values.
Acción
Bio-Rad Laboratories sent an Urgent Product Correction letter dated July 19, 2010, to all customer sites via FedEx. There are two issues related to The EVOLIS Assay Protocol Files (APF) Software that could potentially affect patient results. Issue 1 involves quantitative sample test/calculations/results interpretation for assays with linear regression, point to point or 4PL data reduction. Issue 2 involves sample test results with " Result Report Flags''.
A software patch to correct these two issues will be sent to each customer site.
Bio-Rad Laboratories will work with each customer to complete documentation confirming that the software patch has been successfully installed on each instrument.
If you have any questions or concerns regarding these two issues, please contact Technical Support at 1-800-224-6723, option 2 and then option 3.
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.
Zimmer, inc. has determined that there is a potential for the packages to be mislabeled. specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left.
Acción
Zimmer, Inc. sent Urgent: Device Removal letters, dated July 9, 2010, identifying the affected product and stating the issue. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left. The letter also discussed the clinical implications along with required actions. Customers are to perform a physical count of all affected product and record the data on the Inventory Return Certification Form included with the letter. In addition, customers should complete and return the Inventory Certification and User Facility/HCP Documentation Forms. Affected product along with the Inventory Return Certification Form should be returned. Zimmer, Inc. should be contacted at 1-800-613-6131 if there are any questions or need for additional information.
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.
Zimmer, inc. has determined that there is a potential for the packages to be mislabeled. specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left.
Acción
Zimmer, Inc. sent Urgent: Device Removal letters, dated July 9, 2010, identifying the affected product and stating the issue. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left. The letter also discussed the clinical implications along with required actions. Customers are to perform a physical count of all affected product and record the data on the Inventory Return Certification Form included with the letter. In addition, customers should complete and return the Inventory Certification and User Facility/HCP Documentation Forms. Affected product along with the Inventory Return Certification Form should be returned. Zimmer, Inc. should be contacted at 1-800-613-6131 if there are any questions or need for additional information.
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.
Notas adicionales en la data
Excimer laser system - Product Code LZS
Causa
The failure to comply with minimum system requirements, increased system errors could result, and a miscreated treatment table (incorrect lasik refractive treatment) could result.
Acción
Abbott Medical Optics, Inc. sent an Urgent Medical Device Field Correction letter to all affected customers starting July 15, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were asked to take the following actions:
Surgeons were instructed to complete the facsimile attachment to acknowledge receipt of the notification letter and fax to 714-247-4530.
For those using the affected product a 3.68 OPM disc must be requested by e-mailing a request to OPM@pacful.com.
For any questions please contact AMO Technical Service Representatiave at 1-877-266-4543.
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 recall was initiated because beckman coulter testing indicated that rheumatoid factor (rf) reagent lot m907325 will not remain stable to the labeled expiration date.
Acción
The firm Beckman Coulter, sent a "URGENT: PRODUCT CORRECTIVE ACTION" letter dated June 25, 2010 to the consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to take the following actions:
*Discontinue use and discard appropriately Rheumatoid Factor (RF) reagent lot M907325
*Contact their Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada to discuss reagent replacement options.
*Complete and return the FAX BACK RESPONSE FORM via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd., Brea, California 92821, Mail Code E2.SE.08
Consignees/customers were asked to share this information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. If consignees/customers forwarded the affected products listed above to another laboratory, then they need to also provide a copy of the Product Corrective Action letter to the laboratory.
If they have any questions regarding this Product Corrective Action letter, consignees were told to call Beckman Coulter Customer Support Center (Hotline) at (800) 854-633 in the United States and Canada.
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.
Notas adicionales en la data
Computed Tomography X-Ray System - Product Code JAK
Causa
A defect with the hardware and software displaying the incorrect dose data.
Acción
Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in 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.
Notas adicionales en la data
Computed Tomography X-Ray System - Product Code JAK
Causa
A defect with the hardware and software displaying the incorrect dose data.
Acción
Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in 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.
Notas adicionales en la data
Computed Tomography X-Ray System - Product Code JAK
Causa
A defect with the hardware and software displaying the incorrect dose data.
Acción
Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in 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.
Notas adicionales en la data
Plate, fixation, bone - Product Code HRS
Causa
Inner packaging of sterile product was not sealed. lack of sterility assurance.
Acción
Smith & Nephew issued an "Urgent:: Medical Device Recall" letter dated July 20, 2010 to consignees (International distributors), identifying the issue and affected product. Consignees were requested to identify and quarantine affected stock, and cease distribution. Consignees were instructed to contact Smith and Nephew for a Return Authorization number. The Return Authorization number and an inventory of affected devices are to be recorded on the Verification Section of the notification letter and faxed to the firm. Affected stock is to be sent to Smith & Nephew.
Consignees were requested to notify anyone to whom the product was distributed to also contact the firm for return of the product. Smith & Nephew can be contacted at 1-901-399-5441.
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.
Notas adicionales en la data
System, x-ray, tomography, computed - Product Code JAK
Causa
Toshiba america medical systems (tams) has found that communication may be cut off in the aquilion one/ premium systems, owing to the failure of a part used in the console.
Acción
The firm, Toshiba America Medical Systems (TAMS), sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated July 22, 2010, to its customers. The letter described the product, problem and actions to be taken. The letter informed the customers that a new relay will be installed to prevent the occurrence of the problem within the next 90 days and that their Toshiba Service Representative will contact them to install the part to their Aquilion ONE/Premium System. The customers were instructed to contact their Toshiba Service Representative, if the problem occurs before the corrective action has been taken; to share the information with all users and review radiologists as well as clinical engineering or Biomedical group at their facility, and to complete and return the attached CUSTOMER REPLY FORM via fax to 877-349-3054 or email to raffairs@tams.com.
If you have any questions regarding this letter, please feel free to contact the Director, Regulator Affairs at (800) 421-1968 or your local Toshiba Representative at (800) 521-1968.
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 bladderscan bvi 9600 with aortascan devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.
Acción
Verathon sent an URGENT Medical Device Recall Notification letter dated August 12, 2010 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Verathon provided an addendum to the User Manual with instructions on how to reset the instrument. Customers were advised to:
" Add the enclosed addendum to their current Users Manual.
" Update the application software of the device to v2.7.0 or higher.
If the customers had questions or needed support for the software update process, they were to contact Verathon Medical Customer Care at (425) 867-1348 or (800) 331-2313 or
cservice@verathon.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.
The aortascan ami 9700 devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.
Acción
Verathon sent an URGENT Medical Device Recall Notification letter dated August 12, 2010 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Verathon provided an addendum to the User Manual with instructions on how to reset the instrument. Customers were advised to:
" Add the enclosed addendum to their current Users Manual.
" Update the application software of the device to v2.7.0 or higher.
If the customers had questions or needed support for the software update process, they were to contact Verathon Medical Customer Care at (425) 867-1348 or (800) 331-2313 or
cservice@verathon.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.
The bladderscan bvm 9500 devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.
Acción
Verathon sent an URGENT Medical Device Recall Notification letter dated August 12, 2010 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Verathon provided an addendum to the User Manual with instructions on how to reset the instrument. Customers were advised to:
" Add the enclosed addendum to their current Users Manual.
" Update the application software of the device to v2.7.0 or higher.
If the customers had questions or needed support for the software update process, they were to contact Verathon Medical Customer Care at (425) 867-1348 or (800) 331-2313 or
cservice@verathon.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.
Medical device vent port may be occluded and prevent delivery of priming fluid.
Acción
Consignees were contacted on June 8, 2010, by phone, fax, email and priority mail to advise distributors and end-users of the potential occluded vent port defect and provide instructions for the replacement product recall. Consignees were mailed follow-up communications by priority overnight mail on June 9, 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.
Medical device vent port may be occluded and prevent delivery of priming fluid.
Acción
Consignees were contacted on June 8, 2010, by phone, fax, email and priority mail to advise distributors and end-users of the potential occluded vent port defect and provide instructions for the replacement product recall. Consignees were mailed follow-up communications by priority overnight mail on June 9, 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.
Medical device vent port may be occluded and prevent delivery of priming fluid.
Acción
Consignees were contacted on June 8, 2010, by phone, fax, email and priority mail to advise distributors and end-users of the potential occluded vent port defect and provide instructions for the replacement product recall. Consignees were mailed follow-up communications by priority overnight mail on June 9, 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.
Medical device vent port may be occluded and prevent delivery of priming fluid.
Acción
Consignees were contacted on June 8, 2010, by phone, fax, email and priority mail to advise distributors and end-users of the potential occluded vent port defect and provide instructions for the replacement product recall. Consignees were mailed follow-up communications by priority overnight mail on June 9, 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.
Notas adicionales en la data
Needle, Hypodermic, Single Lumen - Product Code FMI
Causa
Needle cannula may separate from the hub during use.
Acción
Recall letters requesting product return were mailed to all customers on October 8, 2004