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
screwdriver instructions - Product Code ODP
Causa
Tip breakage, due to inadequate instructions for use. the technique guide provided incorrect information related to use of the torque limiting attachment during screw insertion and final tightening.
Acción
All affected Synthes Spine Sales Consultants were notified of the Labeling Correction via email on February 10, 2009. They were instructed to review changes with their surgeons. They were supplied with an electronic version of the corrected Technique Guide on March 11, 2009. All affected Synthes Sales Consultants and Customers were notified of this labeling change via distribution of the updated Technique Guide and a notification letter. This packet was sent via USPS certified mail on March 26, 2009. To ensure a broad and accurate distribution of notification, affected consultants and customers are defined as having been shipped Zero-P 3.0 mm Titanium Cervical Spine Locking Screws. These devices are used only with the Zero-P system.
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 has identified a small number of one source kits and maxpac/total system lots with incorrect use before dates on the outer kit package label. the use before date on the outer label of the kit/pack does not accurately reflect the use before date of the components within the kit/pack. for affected product, the outer label lists a date which exceeds the earliest use before date of the com.
Acción
An "Urgent Medical Device Recall Notice" dated March 23, 2009 was sent to customers describing the affected device. Consignees were asked to quarantine product, complete and sign a certificate indicating acknowledgement of the notification and the amount of affected product at the facility, and to return the affected product.
For further questions, contact Medtronic at 1-763-514-9605.
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 has identified a small number of one source kits and maxpac/total system lots with incorrect use before dates on the outer kit package label. the use before date on the outer label of the kit/pack does not accurately reflect the use before date of the components within the kit/pack. for affected product, the outer label lists a date which exceeds the earliest use before date of the com.
Acción
An "Urgent Medical Device Recall Notice" dated March 23, 2009 was sent to customers describing the affected device. Consignees were asked to quarantine product, complete and sign a certificate indicating acknowledgement of the notification and the amount of affected product at the facility, and to return the affected product.
For further questions, contact Medtronic at 1-763-514-9605.
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 has identified a small number of one source kits and maxpac/total system lots with incorrect use before dates on the outer kit package label. the use before date on the outer label of the kit/pack does not accurately reflect the use before date of the components within the kit/pack. for affected product, the outer label lists a date which exceeds the earliest use before date of the com.
Acción
An "Urgent Medical Device Recall Notice" dated March 23, 2009 was sent to customers describing the affected device. Consignees were asked to quarantine product, complete and sign a certificate indicating acknowledgement of the notification and the amount of affected product at the facility, and to return the affected product.
For further questions, contact Medtronic at 1-763-514-9605.
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
stress treadmill - Product Code IOL
Causa
28 stress and rehab treadmills manufactured between september 2006 and january 2009 may not have received adequate electrical safety testing prior to being shipped from the factory. if these components break down in the field, a patient or operator could be exposed to excess touch currents on the surface of the product. because safety testing may not have allowed for complete evaluation of the el.
Acción
On April 3, 2009 the recalling firms notified consignees by certified letter to domestic customers and via FedEx to international customers with delivery confirmation signature required. Customers were advised to remove treadmill from service until it is tested by a Field Service Engineer.
For customers with questions or those that have not already scheduled a service call with Cardiac Science Field Service Engineers, please contact the firm at 1.800.426.0337, option 1.
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
Image-Intensified Fluoroscopic X-Ray System - Product Code JAA
Causa
The alarm timer is reset after each exposure and therefore never reaches the five minute alarm state unless one exposure exceeds 5 minutes in duration.
Acción
GE Healthcare sent a customer notification out to all sites that have potentially affected systems. GEHC Surgery will also install a software correction into the affected systems in order to resolve this issue at no charge to the customer. Until the GEHC OEC Fluorostar 7900 has received the corrective software installed, they are encouraging facilities to exercise caution in monitoring the amount of cumulative fluoroscopy time when the affected system is in use.
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
Catheter, percutaneous - Product Code DQY
Causa
Boston scientific has initiated a recall of the wiseguide guide catheter. they have received reports of difficulties in connecting the product hubs with the y-adaptors and toughy borst connectors. if there is difficulty making such connection, there is a potential for prolongation or delay of the procedure in order to exchange the catheter or connector. there have been 41 complaints in the us as.
Acción
Consignees were sent a "Boston Scientific Urgent Medical Device Recall" letter dated March 11, 2009. The letter was addressed to Risk Manager/Field Action Contacts describing the problem including instructions for affected device handling and a request to return the enclosed Reply Verification Tracking Form.
Further questions can be addressed to Boston Scientific at 763-494-1634.
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.
Milcam recon iii models were sold to non-dod customers prior to certification and reporting as required in title 21 of the code of federal regulations. conditions of sale were not stated in variance approval letters issued for similar laser products.
Acción
FLIR Systems notified direct account by letter of the Corrective Action Plan and updated certification label that references CDRH issued variance and instructions on how to install it.
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
Intravascular administration set - Product Code FPA
Causa
Device defect is occlusion/no flow.
Acción
An Urgent - Medical Device Recall notice was issued via US Postal Service Certified Mail with registered return receipt mail or FedEx to all customer/distributors in receipt of affected product on 3/27/09. Direct customers received letters addressed to Materials Management that informed them of this recall and provided instructions for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers as requested. Distributors are to immediately discontinue further distribution of the affected product, determine their customers' inventory, and have their customers return the product to them. The attached "Product Removal Acknowledgement" should be used to indicate the specifics of the combined distributor and customer inventories. The Customer Support Department should be contacted to arrange for return. A Customer Support Representative will provide instructions for handling the affected product and assist with replacement product.
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
Intravascular administration set - Product Code FPA
Causa
Device defect is occlusion/no flow.
Acción
An Urgent - Medical Device Recall notice was issued via US Postal Service Certified Mail with registered return receipt mail or FedEx to all customer/distributors in receipt of affected product on 3/27/09. Direct customers received letters addressed to Materials Management that informed them of this recall and provided instructions for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers as requested. Distributors are to immediately discontinue further distribution of the affected product, determine their customers' inventory, and have their customers return the product to them. The attached "Product Removal Acknowledgement" should be used to indicate the specifics of the combined distributor and customer inventories. The Customer Support Department should be contacted to arrange for return. A Customer Support Representative will provide instructions for handling the affected product and assist with replacement product.
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
Intravascular administration set - Product Code FPA
Causa
Device defect is occlusion/no flow.
Acción
An Urgent - Medical Device Recall notice was issued via US Postal Service Certified Mail with registered return receipt mail or FedEx to all customer/distributors in receipt of affected product on 3/27/09. Direct customers received letters addressed to Materials Management that informed them of this recall and provided instructions for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers as requested. Distributors are to immediately discontinue further distribution of the affected product, determine their customers' inventory, and have their customers return the product to them. The attached "Product Removal Acknowledgement" should be used to indicate the specifics of the combined distributor and customer inventories. The Customer Support Department should be contacted to arrange for return. A Customer Support Representative will provide instructions for handling the affected product and assist with replacement product.
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
Intravascular administration set - Product Code FPA
Causa
Device defect is occlusion/no flow.
Acción
An Urgent - Medical Device Recall notice was issued via US Postal Service Certified Mail with registered return receipt mail or FedEx to all customer/distributors in receipt of affected product on 3/27/09. Direct customers received letters addressed to Materials Management that informed them of this recall and provided instructions for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers as requested. Distributors are to immediately discontinue further distribution of the affected product, determine their customers' inventory, and have their customers return the product to them. The attached "Product Removal Acknowledgement" should be used to indicate the specifics of the combined distributor and customer inventories. The Customer Support Department should be contacted to arrange for return. A Customer Support Representative will provide instructions for handling the affected product and assist with replacement product.
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
Intravascular administration set - Product Code FPA
Causa
Device defect is occlusion/no flow.
Acción
An Urgent - Medical Device Recall notice was issued via US Postal Service Certified Mail with registered return receipt mail or FedEx to all customer/distributors in receipt of affected product on 3/27/09. Direct customers received letters addressed to Materials Management that informed them of this recall and provided instructions for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers as requested. Distributors are to immediately discontinue further distribution of the affected product, determine their customers' inventory, and have their customers return the product to them. The attached "Product Removal Acknowledgement" should be used to indicate the specifics of the combined distributor and customer inventories. The Customer Support Department should be contacted to arrange for return. A Customer Support Representative will provide instructions for handling the affected product and assist with replacement product.
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
Intravascular administration set - Product Code FPA
Causa
Device defect is occlusion/no flow.
Acción
An Urgent - Medical Device Recall notice was issued via US Postal Service Certified Mail with registered return receipt mail or FedEx to all customer/distributors in receipt of affected product on 3/27/09. Direct customers received letters addressed to Materials Management that informed them of this recall and provided instructions for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers as requested. Distributors are to immediately discontinue further distribution of the affected product, determine their customers' inventory, and have their customers return the product to them. The attached "Product Removal Acknowledgement" should be used to indicate the specifics of the combined distributor and customer inventories. The Customer Support Department should be contacted to arrange for return. A Customer Support Representative will provide instructions for handling the affected product and assist with replacement product.
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
Intravascular administration set - Product Code FPA
Causa
Device defect is occlusion/no flow.
Acción
An Urgent - Medical Device Recall notice was issued via US Postal Service Certified Mail with registered return receipt mail or FedEx to all customer/distributors in receipt of affected product on 3/27/09. Direct customers received letters addressed to Materials Management that informed them of this recall and provided instructions for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers as requested. Distributors are to immediately discontinue further distribution of the affected product, determine their customers' inventory, and have their customers return the product to them. The attached "Product Removal Acknowledgement" should be used to indicate the specifics of the combined distributor and customer inventories. The Customer Support Department should be contacted to arrange for return. A Customer Support Representative will provide instructions for handling the affected product and assist with replacement product.
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
Intravascular administration set - Product Code FPA
Causa
Device defect is occlusion/no flow.
Acción
An Urgent - Medical Device Recall notice was issued via US Postal Service Certified Mail with registered return receipt mail or FedEx to all customer/distributors in receipt of affected product on 3/27/09. Direct customers received letters addressed to Materials Management that informed them of this recall and provided instructions for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers as requested. Distributors are to immediately discontinue further distribution of the affected product, determine their customers' inventory, and have their customers return the product to them. The attached "Product Removal Acknowledgement" should be used to indicate the specifics of the combined distributor and customer inventories. The Customer Support Department should be contacted to arrange for return. A Customer Support Representative will provide instructions for handling the affected product and assist with replacement product.
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
Failure to provide the certification label required by 21 cfr 1010.2.
Acción
A GE Field Service Representative will visit each affected customer site and affix the certification label required. A Field Modification Instruction (FMI Number 25412) has been developed for release to all facilities in possession of the affected systems.
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
Failure to provide the certification label required by 21 cfr 1010.2.
Acción
A GE Field Service Representative will visit each affected customer site and affix the certification label required. A Field Modification Instruction (FMI Number 25412) has been developed for release to all facilities in possession of the affected systems.
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
Detector and alarm, arrhythmia - Product Code DSI
Causa
The 19" model vg930m viewsonic flat panel lcd display may have faulty capacitors at certain locations in the power supply section. the faulty capacitors may cause a loss of power to the display resulting in the display screen going dark and loss of both visual and secondary patient alarms.
Acción
On May 1, 2009, Welch Allyn Protocol, Inc. sent out recall notification to their consignees in via UPS and US Postal Certified Mail.
The letter describes the recalled product as 19" model VGM930M ViewSonic flat panel LCD display with serial numbers less than QC2082880001.
For the Welch Allyn service contract consignees/customers, the firm's Field Service Engineer will replace the LCD monitor for the consignees. The consignees could contact Technical Support at 1-800-289-2501.
For the Warranty/non-Warranty contract consignees/customers-For the Welch Allyn service contract consignees, Stericycle Return Management Services (RMS) will manage all recall and recovery initiatives.
Consignees/customers can call Welch Allyn Customer Care at 1-800-535-6663 for any questions or concern about this recall.