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
Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
Acción
Siemens sent a Customer Information Letter on December 1, 2011 to all affected customers. The letter idenfied what is the issue, when does the issue occur and what Siemens will do to address the issue. The letter recommend that the Customer Information letter be included in the Linear Accelerator System Owner manual chapter Safety Advisory Letters.
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
Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
Acción
Siemens sent a Customer Information Letter on December 1, 2011 to all affected customers. The letter idenfied what is the issue, when does the issue occur and what Siemens will do to address the issue. The letter recommend that the Customer Information letter be included in the Linear Accelerator System Owner manual chapter Safety Advisory Letters.
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
Low energy direct current thermal ablation system - Product Code OAB
Causa
Angiodynamics was marketing the nanoknife system with the ablation zone estimator feature in the us without fda clearance.
Acción
AngioDynamics sent an Urgent - Medical Device Correction letter dated December 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use the User's Manual that was supplied with the generator when it was purchased. Instructions include discarding their current manual and troubleshooting guide. A replacement manual will be provided with the Field Safety Notice; the troubleshooting guide will not be replaced. Customers were instructed to complete the Reply Form and fax to AngioDynamics at 518-798-1360. If customers further distributed the affected product, they should inform those accounts of the field correction.
Angiodynamics will also disable the AZE feature during a schedule service visit.
For questions regarding this recall call 1-800-772-6446 or e-mail customerservice@angiodynamics.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.
During in-house inspection, terumo cardiovascular systems discovered one soft-flow aortic cannula with a hole in the tip, just above the suture ball.
Acción
Terumo sent an URGENT MEDICAL DEVICE RECALL letter dated February 23, 2012 via Federal Express to all US customers. Terumo Foreign Affiliates received the recall notification via email on February 24th, 2012. The letters identified the affected products, reson for removal, potential hazard, affected population and actions to be taken. Customers were instructed to review the Medical Device Removal notice, assure that all users are aware of the notice, confirm receipt of this communication by faxing the attached Customer Response Form to the fax number provided or email to tcvs.recall@terumomedical.com and call Terumo CVS Customer Service for a Returned Goods Authorization (RGA) number. For questions call Terumo CVS Customer Service at 1-800-521-2818.
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 in-house inspection, terumo cardiovascular systems discovered one soft-flow aortic cannula with a hole in the tip, just above the suture ball.
Acción
Terumo sent an URGENT MEDICAL DEVICE RECALL letter dated February 23, 2012 via Federal Express to all US customers. Terumo Foreign Affiliates received the recall notification via email on February 24th, 2012. The letters identified the affected products, reson for removal, potential hazard, affected population and actions to be taken. Customers were instructed to review the Medical Device Removal notice, assure that all users are aware of the notice, confirm receipt of this communication by faxing the attached Customer Response Form to the fax number provided or email to tcvs.recall@terumomedical.com and call Terumo CVS Customer Service for a Returned Goods Authorization (RGA) number. For questions call Terumo CVS Customer Service at 1-800-521-2818.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
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 in-house inspection, terumo cardiovascular systems discovered one soft-flow aortic cannula with a hole in the tip, just above the suture ball.
Acción
Terumo sent an URGENT MEDICAL DEVICE RECALL letter dated February 23, 2012 via Federal Express to all US customers. Terumo Foreign Affiliates received the recall notification via email on February 24th, 2012. The letters identified the affected products, reson for removal, potential hazard, affected population and actions to be taken. Customers were instructed to review the Medical Device Removal notice, assure that all users are aware of the notice, confirm receipt of this communication by faxing the attached Customer Response Form to the fax number provided or email to tcvs.recall@terumomedical.com and call Terumo CVS Customer Service for a Returned Goods Authorization (RGA) number. For questions call Terumo CVS Customer Service at 1-800-521-2818.
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 in-house inspection, terumo cardiovascular systems discovered one soft-flow aortic cannula with a hole in the tip, just above the suture ball.
Acción
Terumo sent an URGENT MEDICAL DEVICE RECALL letter dated February 23, 2012 via Federal Express to all US customers. Terumo Foreign Affiliates received the recall notification via email on February 24th, 2012. The letters identified the affected products, reson for removal, potential hazard, affected population and actions to be taken. Customers were instructed to review the Medical Device Removal notice, assure that all users are aware of the notice, confirm receipt of this communication by faxing the attached Customer Response Form to the fax number provided or email to tcvs.recall@terumomedical.com and call Terumo CVS Customer Service for a Returned Goods Authorization (RGA) number. For questions call Terumo CVS Customer Service at 1-800-521-2818.
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 in-house inspection, terumo cardiovascular systems discovered one soft-flow aortic cannula with a hole in the tip, just above the suture ball.
Acción
Terumo sent an URGENT MEDICAL DEVICE RECALL letter dated February 23, 2012 via Federal Express to all US customers. Terumo Foreign Affiliates received the recall notification via email on February 24th, 2012. The letters identified the affected products, reson for removal, potential hazard, affected population and actions to be taken. Customers were instructed to review the Medical Device Removal notice, assure that all users are aware of the notice, confirm receipt of this communication by faxing the attached Customer Response Form to the fax number provided or email to tcvs.recall@terumomedical.com and call Terumo CVS Customer Service for a Returned Goods Authorization (RGA) number. For questions call Terumo CVS Customer Service at 1-800-521-2818.
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.
Instructions for use for the dlp single stage venous cannulae are in the process of being updated. the current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated instructions for use. do not use this product for extended terms such as ventricular assist procedures.
medtronic has received two reports of patient deaths due to p.
Acción
Medtronic sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue.
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.
Instructions for use for the dlp single stage venous cannulae are in the process of being updated. the current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated instructions for use. do not use this product for extended terms such as ventricular assist procedures.
medtronic has received two reports of patient deaths due to p.
Acción
Medtronic sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue.
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.
Instructions for use for the dlp single stage venous cannulae are in the process of being updated. the current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated instructions for use. do not use this product for extended terms such as ventricular assist procedures.
medtronic has received two reports of patient deaths due to p.
Acción
Medtronic sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue.
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.
Instructions for use for the dlp single stage venous cannulae are in the process of being updated. the current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated instructions for use. do not use this product for extended terms such as ventricular assist procedures.
medtronic has received two reports of patient deaths due to p.
Acción
Medtronic sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue.
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.
Instructions for use for the dlp single stage venous cannulae are in the process of being updated. the current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated instructions for use. do not use this product for extended terms such as ventricular assist procedures.
medtronic has received two reports of patient deaths due to p.
Acción
Medtronic sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue.
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.
Instructions for use for the dlp single stage venous cannulae are in the process of being updated. the current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated instructions for use. do not use this product for extended terms such as ventricular assist procedures.
medtronic has received two reports of patient deaths due to p.
Acción
Medtronic sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue.
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.
Instructions for use for the dlp single stage venous cannulae are in the process of being updated. the current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated instructions for use. do not use this product for extended terms such as ventricular assist procedures.
medtronic has received two reports of patient deaths due to p.
Acción
Medtronic sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue.
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
Processor, tissue, automated - Product Code IEO
Causa
There is a potential malfunction with the device in autorotation mode, which can lead to incorrect reagent handling of the device. the end result may lead to damage or to loss of tissue specimens.
Acción
Leica Microsystems sent a Urgent Medical device Recall letter dated March 30, 2012, to all affected customers in the U.S. on the same date. The letter identified the product the problem and the action needed to be taken by the customer.
The customer was instructed of the potential malfunction of the device in the autorotation mode, which could lead to damage or loss of tissue specimens.
The letter provided instructions on what the customer should do with the recalled product in the interim before the software fix can be installed. They were instructed to follow the steps below:
1. Remove and dispose all reagents including Paraffin and clean all bottles and Paraffin bathes.
2. Conduct a "Smart Clean" (IFU, chapter 6.1.4).
3. In Submenu "System Setup", here at "Program options", respectively "Station sequence", customer shall switch from "Concentration" to "Auto by RMS".
4. Prestored Xylene protocols shall be used instead of autorotation protocols (IFU, chapter 5.6.2 "Time - optimized Xylene infiltration programs"). Here you find the five validated programs which need to be copied to Favorite programs (IFU, chapter 5.5.3).
5. Use the Reagents, bottle set up from "Time optimized Xylene programs" (IFU, chapter 5.6.2., page 134) and implement them into submenu "Reagents" (IFU, chapter 5.2. following pages).
6. In submenu "The RMS system adjusting warning thresholds rules" (IFU, chapter 5.2.2) the validated reagent thresholds need to be implemented into Submenu "Reagents" (IFU, chapter 5.2).
7. Current Reagent management values are visible within Submenu "Reagent Status" (IFU, chapter 5.2.3)
The customers were also informed that their Leica Microsystems representative will them to make the necessary arrangements to complete a software upgrade at no charge.
The customers were also requested to sign and date the enclosed acknowledgement form and fax it back to Leica at 847-236-3747 or e-mail it to LMGRA@leica-microsystems.com within 10 working da
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.
Instructions for use for the dlp single stage venous cannulae are in the process of being updated. the current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated instructions for use. do not use this product for extended terms such as ventricular assist procedures.
medtronic has received two reports of patient deaths due to p.
Acción
Medtronic sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue.
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.
Tip of hex-head screwdriver may break off during use in hip replacement procedure.
Acción
Ortho Development Corporation sent an "URGENT!! DEVICE RECALL" letter dated December 19, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check to see if they have the affected device. Customers who have the device are to return the device to the firm, immediately. The firm will provide suitable replacements. Contact the Regulatory Affairs Manager for questions regarding this notice.
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
Cardiovascular procedure kit - Product Code OEZ
Causa
Navilyst medical has received reports of damaged manifolds contained in certain namic convenience kits which may result in air injection during certain procedures.
Acción
Navilyst Medical sent an Urgent Medical Device Recall- Immediate Action Required letter dated December 19, 2011 and a Reply Verification Tracking Form to all affected consignees via Federal Express or email. The letter identified the product, description of problem, and actions to be taken Customers were instructed to 1) IMMEDIATELY DISCONTINUE USE; 2) remove the recalled product from your inventory (whether in Labs, Central Supply, Shipping and Receiving or ANY other location); 3) segregate this product in a secure location for return to Navilyst Medical, Inc; 4) immediately forward a copy of this recall notification to all sites to which you have distributed affected product; 5) complete and return the Reply Verification Tracking Form; and 6) package and return the recalled product per the instruction provided.
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
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Causa
Optiflux f250nre hemodialyzers have increased risk of an internal blood leak.
Acción
Fresenius Medical Care North America contacted customers by telephone on December 27, 2011, and sent a Customer Notification letter dated December 27, 2011, via certified mail return receipts and fax - back requested to all affected customers.
Customers were instructed to examine your stock of dialyzers, and isolate and discontinue use of the before mentioned lots. If you have identified dialyzers from the recalled lots, please contact Customer Service for a Return Goods Authorization. We will pick up the product you currently have in stock and supply replacement product. All products for return will be picked up during your next scheduled Fresenius delivery. Promtly fill out the fax-back reply form attached to the notification. Please do not return used dialyzers.
For further questions, please call 1 (800) 662-1237.
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
Film, radiographic - Product Code IWZ
Causa
Kodak dryview dvb film is being recalled because it does not meet the specification for maximum density.
Acción
Carestream Health Inc. sent an "URGENT PRODUCT REMOVAL" letter dated December 20, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to identify, segregate, and return any affected product to the firm. A Product Information Form was attached to the letter for customers to complete and return via fax to 541-831-7101. Contact Technical Support at 1-800-328-2910 for questions regarding this notice.
Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
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.
Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
Acción
Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.
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.
Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
Acción
Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.