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
Radioimmunoassay, estradiol - Product Code CHP
Causa
Siemens healthcare diagnostics has confirmed a negative bias for advia centaur enhanced estradiol (ee2) on the advia centaur, advia centaur xp and advia centaur xpt systems when calibrating with calibrator 30 kit lots ending in 21 (c3021) as compared to calibrator 30 kit lots ending in 20 (c3020).
Acción
An Urgent Medical Device Recall letter dated June 7, 2017 was distributed to all customers in the United States and an
Urgent Field Safety Notice was distributed to all customers outside the United States who have
received ADVIA Centaur Systems Calibrator 30 kit lot ending in 21(C3021). These letters instruct
customers who operate the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT
systems to discontinue use of C3021 . The letters inform customers that Calibrator 30 kit lots
ending in 20 (C3020) and 23 (C3023) are not impacted and can be used. The letters inform
customers who operate ADVIA Centaur CP systems to continue using their inventory of C3021,
as they are not impacted by this issue.
All affected domestic customers were sent a hard copy of the Urgent Medical Device Recall via
Federal Express. Fax-back forms will be used to confirm that the customers received the Urgent
Medical Device Recall 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.
The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
Acción
A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi
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
unknown device name - Product Code N/A
Causa
Certain lots of the qiaamp dsp virus kit, ref
60704, used in analytic
workflows could result in decreased performance.
Acción
Qiagen sent ffected customers and commercial partners "Urgent Notice of Product Field Action", dated June 22, 2017 via an e-mail containing a letter as pdf. In the letter, customers were informed of the reason for recall, with an overview of affected products, detailed description of issue, consequences of the issue, actions to be taken by the customer/user, completion of the acknowledgement of receipt form, contact information and the commercial partners are instructed to forward , actions that have been initiated by AIAGEN, the letter to their customers.
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
Laparoscope, general & plastic surgery - Product Code GCJ
Causa
Plastic handle is breaking off of shaft inhibiting proper removal per instructions for use.
Acción
Consignees were notified via email on 07/19/2017. Instructions included
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
Accelerator, linear, medical - Product Code IYE
Causa
Potential for positional errors following automatic table movement (atm).
Acción
Customers were notified via letter on about [DATE]. Instructions include to post the notice in a place accessible to all users until the action is closed and to advise appropriate personnel working with the affected product of the recall action. Additionally Elekta plans to release Integrity R4.0.0, which should identify positional errors over 5 mm, in the first half of 2018.
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
Accelerator, linear, medical - Product Code IYE
Causa
Potential for positional errors following automatic table movement (atm).
Acción
Customers were notified via letter on about [DATE]. Instructions include to post the notice in a place accessible to all users until the action is closed and to advise appropriate personnel working with the affected product of the recall action. Additionally Elekta plans to release Integrity R4.0.0, which should identify positional errors over 5 mm, in the first half of 2018.
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
Implant, endosseous, root-form - Product Code DZE
Causa
Two lots of the tapered screw-vent implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Acción
On 11/29/2017, customers were notified via letter. Instructions for distributors include to ensure that affected team members are aware of the recall, immediately locate and quarantine affected devices in inventory, notify consignees if product was distributed, make arrangements to immediately return affected devices, and complete and return the Attachment 1 - Inventory Return Certification Form.
Instructions for clinicians include to review the recall notice, examine inventory for affected devices, complete and return the Attachment 2 - Certificate of Acknowledgement, and return all affected devices.
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
Implant, endosseous, root-form - Product Code DZE
Causa
Two lots of the tapered screw-vent implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Acción
On 11/29/2017, customers were notified via letter. Instructions for distributors include to ensure that affected team members are aware of the recall, immediately locate and quarantine affected devices in inventory, notify consignees if product was distributed, make arrangements to immediately return affected devices, and complete and return the Attachment 1 - Inventory Return Certification Form.
Instructions for clinicians include to review the recall notice, examine inventory for affected devices, complete and return the Attachment 2 - Certificate of Acknowledgement, and return all affected devices.
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
Laparoscope, general & plastic surgery - Product Code GCJ
Causa
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Acción
On about 11/17/2017 letters were sent by certified mail with tracking information to all domestic accounts and International Stryker sites were notified by email. Instructions include to inform individuals who need to be aware of the device recall, examine all stock areas and/or operating room storage for affected product quarantine and discontinue use of the recalled devices, complete the acknowledgement form, and if affected product is found contact Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return.
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
One lot of evos 2.4mm flex plate 6 hole packaging contained templates.
Acción
Smith & Nephew Inc. initiated its recall by email on November 29, 2017. The consignee was directed to return the recalled product. For further questions, please call (901) 396-2121.
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
infusion pump - Product Code FRN
Causa
Certain cadd legacy 1, ambulatory infusion pumps, may contain non-matching serial numbers. the label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of the pump.
Acción
The recall notices were disseminated via FedEx to US consignees on November 22, 2017. The recall notices were disseminated via email to Australian consignees on November 27, 2017. The consignee was directed to turn on the pump and check the serial against the serial number on the label. If they did not match, then they were directed to return the unit.
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
Stents, drains and dilators for the biliary ducts - Product Code FGE
Causa
Potential for cracked luer hubs.
Acción
On November 15, 2017 the firm sent letter to their customers indicating the following:
The purpose of this communication is to inform you of a potential leakage scenario with the S.M.A.R.T.¿ Flex Biliary Stent System. The leak may occur due to potentially cracked hubs in some units from within the 29 lots listed in this letter.
Inspection details:
As stated in the Instructions for use, users are warned that the device should not be used if the outer sheath cannot be flushed. Inspect for leakage during preparation of the device. Leakage may be more likely in the affected product due to cracks in the luer. At time of actual flushing, if there is no leakage observed, the product may be safely used.
Available Assistance:
We can provide help if you have any questions regarding this Correction.
For any health care professional with medical concerns, please contact Cordis to speak to a clinician at 1-800-327-7714 Option 3, Monday through Friday from 9:00 AM to 5:00 PM EST.
For questions related to the Correction that are not adequately addressed in this letter, please contact the Cordis Field Action Coordinator Hal Baden at (786) 313-2365.
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 prior study is being replaced in the workflow step, in certain scenarios (based on the display protocol configuration) the prior study will only be replaced in the active workflow step and not show in all other workflow steps. the other workflow steps will continue to show the initially loaded study.
Acción
Siemens Healthineers distributed Urgent Customer Advisory Notices to their customers via courier service. Customers were advised to always verify date and time of the displayed study during workflow step change to ensure that the desired images are being displayed. Otherwise, please replace the displayed initial study in the workflow step with the expected study. Customers with any questions, call Siemens Customer Care Centre at 888-826-9702.
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 ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
Acción
A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi
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, stationary - Product Code KPR
Causa
An image was obtained with over exposure during a thorax examination using the aec function.
Acción
On June 22, 2017, Samsung distributed Urgent Field Safety Notices & acknowledgment forms to their customers via email.
INSTRUCTIONS FOR END USERS:
1) Please read the Field Safety Notice documentation in detail.
2) Follow the instructions provided in this FSN in relation to any actions which are required of you.
3) Complete the provided acknowledgement form and return to your supplier as soon as possible. Your organizations reply is the evidence we need to monitor the progress of the corrective actions.
4) If required and instructed by this FSN documentation, please undertake all relevant service actions as soon as is practicably possible.
INSTRUCTIONS FOR DISTRIBUTORS:
1) Please read the Field Safety Notice documentation in detail.
2) Please review and complete the acknowledgement form provided in this FSN and return to Samsung as soon as possible.
Please pass this entire package of FSN documentation onto your customers and ask them to return the completed acknowledgement form. Please forward copies of acknowledgements from end users onto to the email addresses stated above. Samsung require this evidence to monitor the progress of the corrective actions.
4) If required and instructed by this FSN documentation, please undertake all relevant service actions as soon as is practicably possible.
Customers with questions were advised to contact their local 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.
Notas adicionales en la data
Needle, hypodermic, single lumen - Product Code FMI
Causa
Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
Acción
On July 10, 2017, Arrow International distributed Urgent Medical Device Recall
notice and acknowledgment forms to customers. Customers are
advised to take the following actions:
1. If you have affected stock, immediately discontinue use and quarantine any products listed in the notice, so that the affected products can be returned to Arrow.
2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419- 8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you
with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International.
3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter. If you have any other questions, feel free to contact your local sales representative or Customer Service at 18662466990.
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
Accelerator, linear, medical - Product Code IYE
Causa
Uncontrolled couch z-axis movement (descent).
Acción
Accuray sent an Urgent Field Safety Notice letter dated November 8, 2017, to affected customers. The letter identified the affected product, problem and actions to be taken.
The letter stated the following:
"Accuray(R) will correct all affected High-Performance Patient Couches. An Accuray representative will contact you to arrange a time to update your system. The update includes the installation of TomoTherapy(R)' H(TM) Series
software version 2.1.2 (Hi ¿Art(R) vS.1.2) on your system, as well as the replacement of cables within the couch subsystem."
For questions contact Accuray Customer Support by phoning the regional support lines.
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
Accelerator, linear, medical - Product Code IYE
Causa
Uncontrolled couch z-axis movement (descent).
Acción
Accuray sent an Urgent Field Safety Notice letter dated November 8, 2017, to affected customers. The letter identified the affected product, problem and actions to be taken.
The letter stated the following:
"Accuray(R) will correct all affected High-Performance Patient Couches. An Accuray representative will contact you to arrange a time to update your system. The update includes the installation of TomoTherapy(R)' H(TM) Series
software version 2.1.2 (Hi ¿Art(R) vS.1.2) on your system, as well as the replacement of cables within the couch subsystem."
For questions contact Accuray Customer Support by phoning the regional support lines.
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
Accelerator, linear, medical - Product Code IYE
Causa
Uncontrolled couch z-axis movement (descent).
Acción
Accuray sent an Urgent Field Safety Notice letter dated November 8, 2017, to affected customers. The letter identified the affected product, problem and actions to be taken.
The letter stated the following:
"Accuray(R) will correct all affected High-Performance Patient Couches. An Accuray representative will contact you to arrange a time to update your system. The update includes the installation of TomoTherapy(R)' H(TM) Series
software version 2.1.2 (Hi ¿Art(R) vS.1.2) on your system, as well as the replacement of cables within the couch subsystem."
For questions contact Accuray Customer Support by phoning the regional support lines.