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, nuclear magnetic resonance imaging - Product Code LNH
Causa
Ingenia customers have experienced clamping of the foot under the central column of the height adjustable flex trak trolley and the trolley variable height irf.
Acción
Philips sent an Urgent Field Safety Notice (FSN78100414) dated May 2014 via certified mail to US and Canadian consignees. Philips Key Market representatives will distribute the letter internationally. The letter identified the affected product, explains the problem, actions that should be taken in order to prevent risks for users, and the actions planned by Philips to correct the problem. On May 31, 2014, Philips released a Field Change Order that requires service engineers to replace the front and rear covers of the Ingenia MR FlexTrak Trolley with new covers with protection bumper that prevents foot clamping.
For further information and support concerning this issue, consignees should contact their local Philips representative at 1-800-722-9377.
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.
Several attachments and handpieces failed to meet the expected sterility assurance level (sal) when sterilized by the method that is specified in the current directions for use (dfu) provided with the device.
Acción
Customers were notified 05/08/2014 by a Return Receipt Requested letter from Anspach with an URGENT: Medical Device Labeling Correction announcement, REGARDING: STERRAD 100S Hydrogen Peroxide Gas Plasma Technology no longer recommended for sterilization of Anspach products. The letter identified the problem and actions to be taken by the customer. Customers were to complete and return the attached reply form. If the products were distributed further, then those customers should have been notified as well. Customers were to contact Anspach Customer Support at 1-800-327-6887 if they want copies of the revised labeling.
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, nuclear magnetic resonance imaging - Product Code LNH
Causa
Ingenia customers have experienced clamping of the foot under the central column of the height adjustable flex trak trolley and the trolley variable height irf.
Acción
Philips sent an Urgent Field Safety Notice (FSN78100414) dated May 2014 via certified mail to US and Canadian consignees. Philips Key Market representatives will distribute the letter internationally. The letter identified the affected product, explains the problem, actions that should be taken in order to prevent risks for users, and the actions planned by Philips to correct the problem. On May 31, 2014, Philips released a Field Change Order that requires service engineers to replace the front and rear covers of the Ingenia MR FlexTrak Trolley with new covers with protection bumper that prevents foot clamping.
For further information and support concerning this issue, consignees should contact their local Philips representative at 1-800-722-9377.
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 blood pressure (bp) circuit occasionally fails to inflate the blood pressure cuff and the bp circuit fails to activate, resulting in no bp measured.
Acción
Recall notification letters sent to customers on July 8-9, 2014 by registered mail.
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.
Integra lifesciences is recalling newport system mis rod, 2 because it may be up to 30 degrees offset from specification requirements causing misalignment with the inserter. this could potentially result in the lordosis of the rod not aligning with the handle when the inserter is used in accordance with the current newport mis system surgical technique.
Acción
A customer notification letter was sent on 6/9/14 to their customers and distributors who purchased the Integra NewPort System MIS Rod, 2 to inform them there may be a potential that the hex on some NewPort System MIS Rod, 2 are up to 30 degrees offset from specification requirements causing misalignment with the inserter. Customers are instructed to complete and return the customer response form and return by email or fax as indicated on the form. Customers with questions are instructed to contact Customer Service at (866) 942-8698.
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.
Tritanium patella inserter instrument fracture during implantation. .
Acción
Stryker Orthopaedics issued an "Urgent Medical Device Recall Notification" letters/Notification Acknowledgement forms dated May 7, 2014 to their customers via Fed-Ex on May 7, 2014. The notification informs the customers of the issue(s) with the affected product; potential hazards; and how to identify and handle any affected product. Customers were instructed to return any affected product to Stryker Orthopaedics and fill out and return the enclosed Notification Acknowledgement form. For questions call (1-201-972-2100).
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
Shunt, central nervous system and components - Product Code JXG
Causa
Medtronic neurosurgery is recalling the medtronic duet external drainage and monitoring systems because the patient line tubing in the duet external drainage and monitoring systems may become disconnected from the patient line stopcock.
Acción
An Urgent Medical Device Recall letter, dated 6/9/14, was sent to all their customers who purchased the Medtronic Duet External Drainage and Monitoring Systems. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to cease use of the affected product, return any used units, account for any product used and verify that connections are in the condition as stated in the Instructions for Use for product currently in use. Additionally, customers are to complete the Customer Product Accountability Form. Customers with questions about the recall letter are instructed to contact Bob Shokoohi at (805) 571-8725.
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
Shunt, central nervous system and components - Product Code JXG
Causa
Medtronic neurosurgery is recalling the medtronic duet external drainage and monitoring systems because the patient line tubing in the duet external drainage and monitoring systems may become disconnected from the patient line stopcock.
Acción
An Urgent Medical Device Recall letter, dated 6/9/14, was sent to all their customers who purchased the Medtronic Duet External Drainage and Monitoring Systems. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to cease use of the affected product, return any used units, account for any product used and verify that connections are in the condition as stated in the Instructions for Use for product currently in use. Additionally, customers are to complete the Customer Product Accountability Form. Customers with questions about the recall letter are instructed to contact Bob Shokoohi at (805) 571-8725.
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
Shunt, central nervous system and components - Product Code JXG
Causa
Medtronic neurosurgery is recalling the medtronic duet external drainage and monitoring systems because the patient line tubing in the duet external drainage and monitoring systems may become disconnected from the patient line stopcock.
Acción
An Urgent Medical Device Recall letter, dated 6/9/14, was sent to all their customers who purchased the Medtronic Duet External Drainage and Monitoring Systems. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to cease use of the affected product, return any used units, account for any product used and verify that connections are in the condition as stated in the Instructions for Use for product currently in use. Additionally, customers are to complete the Customer Product Accountability Form. Customers with questions about the recall letter are instructed to contact Bob Shokoohi at (805) 571-8725.
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
Shunt, central nervous system and components - Product Code JXG
Causa
Medtronic neurosurgery is recalling the medtronic duet external drainage and monitoring systems because the patient line tubing in the duet external drainage and monitoring systems may become disconnected from the patient line stopcock.
Acción
An Urgent Medical Device Recall letter, dated 6/9/14, was sent to all their customers who purchased the Medtronic Duet External Drainage and Monitoring Systems. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to cease use of the affected product, return any used units, account for any product used and verify that connections are in the condition as stated in the Instructions for Use for product currently in use. Additionally, customers are to complete the Customer Product Accountability Form. Customers with questions about the recall letter are instructed to contact Bob Shokoohi at (805) 571-8725.
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
Shunt, central nervous system and components - Product Code JXG
Causa
Medtronic neurosurgery is recalling the medtronic duet external drainage and monitoring systems because the patient line tubing in the duet external drainage and monitoring systems may become disconnected from the patient line stopcock.
Acción
An Urgent Medical Device Recall letter, dated 6/9/14, was sent to all their customers who purchased the Medtronic Duet External Drainage and Monitoring Systems. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to cease use of the affected product, return any used units, account for any product used and verify that connections are in the condition as stated in the Instructions for Use for product currently in use. Additionally, customers are to complete the Customer Product Accountability Form. Customers with questions about the recall letter are instructed to contact Bob Shokoohi at (805) 571-8725.
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
Set, i.V. Fluid transfer - Product Code LHI
Causa
If the universal ingredient (ui) in an active configuration is changed using the configuration editor, a flush of the outlet pump tube will not be initiated by the software. it could result in the original ui remaining in the tube which could be delivered into the next bag.
Acción
An Urgent Device Correction communication via 1st class mail was mailed on July 14, 2014, informing customers of a potential issue if the universal ingredient in an active configuration is changed using the Configuration Editor rather than following the normally prescribed and supported methods as outlined in the Operator Manual.
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 charged-particle radiation therapy system - Product Code IYE
Causa
A safety risk exists with automatically sequenced treatment technique using the simtec auto field option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.
Acción
An Urgent Medical Device Correction Field Safety Notice Letter was sent to end users on/about June 2014 which described the product, problem, and actions to be taken to avoid encountering the safety risk to patients and users.
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.
Report of the product penetrating the sterile barrier; this
could render the product unsterile.
Acción
Vascular Technology sent an Urgent Medical Device Recall letter dated May 28, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
This recall has been initiated due to a report of the product penetrating the sterile barrier; this could render the product unsterile. Use of this product may lead to infection in the patient.
Please immediately examine your inventory and return all product subject to recall to Vascular Technology at the above mentioned address. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall.
Your notification to your customer must include instructions telling your customer to return the recalled product if unused or to account for the recalled product if it has been used.
For further questions please call (603) 594-9700.
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.
Report of the product penetrating the sterile barrier; this
could render the product unsterile.
Acción
Vascular Technology sent an Urgent Medical Device Recall letter dated May 28, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
This recall has been initiated due to a report of the product penetrating the sterile barrier; this could render the product unsterile. Use of this product may lead to infection in the patient.
Please immediately examine your inventory and return all product subject to recall to Vascular Technology at the above mentioned address. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall.
Your notification to your customer must include instructions telling your customer to return the recalled product if unused or to account for the recalled product if it has been used.
For further questions please call (603) 594-9700.
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.
Report of the product penetrating the sterile barrier; this
could render the product unsterile.
Acción
Vascular Technology sent an Urgent Medical Device Recall letter dated May 28, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
This recall has been initiated due to a report of the product penetrating the sterile barrier; this could render the product unsterile. Use of this product may lead to infection in the patient.
Please immediately examine your inventory and return all product subject to recall to Vascular Technology at the above mentioned address. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall.
Your notification to your customer must include instructions telling your customer to return the recalled product if unused or to account for the recalled product if it has been used.
For further questions please call (603) 594-9700.
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.
Report of the product penetrating the sterile barrier; this
could render the product unsterile.
Acción
Vascular Technology sent an Urgent Medical Device Recall letter dated May 28, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
This recall has been initiated due to a report of the product penetrating the sterile barrier; this could render the product unsterile. Use of this product may lead to infection in the patient.
Please immediately examine your inventory and return all product subject to recall to Vascular Technology at the above mentioned address. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall.
Your notification to your customer must include instructions telling your customer to return the recalled product if unused or to account for the recalled product if it has been used.
For further questions please call (603) 594-9700.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
During an in-process inspection, terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded finished product specifications.
Acción
Terumo sent an Urgent Medical Device Recall letters dated June 27, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Review this Medical Device Recall notice, 2. Assure that all users in your institution have received notice of this issue and remove any affected units from use, 3. Fill out the Product Tracking Sheet (enclosed), indicating the number of affected units at your institution and fax to 1-877-907-7509 or email to terumo4967@stericycle.com. 4. Complete the Packing Slip (enclosed) and follow the packing instructions to return the affected product, and 5. Terumo CVS will issue credit once the affected units are returned. For questions call Terumo CVS c/o Stericycle 1-866-629-6181.
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
Instrument for auto reader & interpretation of overnight suscept. Systems - Product Code LRG
Causa
Springs contained in the access door hinge assembly on the walk away plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers.
Acción
Urgent Medical Device Recall notification letter was sent to all affected US customers on June 2nd by Federal Express.
OUS notifications were also sent to regional Siemens organizations who distributed in-country notifications and relevant notifications.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
During an in-process inspection, terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded finished product specifications.
Acción
Terumo sent an Urgent Medical Device Recall letters dated June 27, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Review this Medical Device Recall notice, 2. Assure that all users in your institution have received notice of this issue and remove any affected units from use, 3. Fill out the Product Tracking Sheet (enclosed), indicating the number of affected units at your institution and fax to 1-877-907-7509 or email to terumo4967@stericycle.com. 4. Complete the Packing Slip (enclosed) and follow the packing instructions to return the affected product, and 5. Terumo CVS will issue credit once the affected units are returned. For questions call Terumo CVS c/o Stericycle 1-866-629-6181.
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.
Led battery chargers may prematurely fail and will not charge the led battery as intended.
Acción
Integra initiated a voluntary recall on June 11, 2014 to consignees that have been shipped affected product lots of Integra¿ LED Battery Chargers, Catalogue No. 90523.
The written notifications were delivered to US consignees by traceable courier service and non-US consignees by traceable email or facsimile. The consignee notification:
Advises them of the nature of the issue and the potential for an adverse patient
consequence. Advises them to review their inventory and how to determine if they have affected battery chargers. Advises them to immediately stop the use or distribution of any affected product lot numbers they may have.
Requests they identify and report to Integra if they do or do not have any unexpired affected product lots.
Advises them replacements battery chargers will be shipped for any affected products they affirm are in their possession and how to return their affected
product. Questions regarding these instructions, please contact Integra Customer Service at 1-800-431-1123 or your Integra sales
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 solid phase reagent in some of the advia centaur¿ tni -ultra readypacks¿, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.
Acción
An Urgent medical Device Correction (UMDC) was mailed, via FedEx, to all affected Siemens Healthcare Diagnostics customers in the United States on May 30, 2014 for customer receipt on June 2, 2014. All international customers were provided with a copy of the Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each country's local regulations and procedures. Each customer is asked to complete a fax-back form.
This notice informed the customers of the potential for incorrect control and patient results due to solid phase which is darker in appearance. The notice instructs customers to place one TnI-Ultra ReadyPack on the system at a time and to calibrate and run controls on each ReadyPack to ensure accurate control and patient values. Patient TnI-Ultra results produced with this assay are acceptable if they follow acceptable calibration with valid quality control results. Upon receipt of kit lots ending in 086 and higher, calibration of each ReadyPack is not required. This notice should be reviewed with the facility's laboratory or medical director.
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.
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.