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
Siemen's issued a customer information letter under update instruction th016/12s to alert all its affected customers of the software issues. the software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
Acción
Siemens Medical Solutions sent a Customer Information letter via mail to all affected customers. The letter identified the affected product, problem and provide instructions on the correction. Customers were instructed to include the Customer Information letter in the Owner Manual chapter "Safety Advisory Letters".
9-16-13 UPDATE: - Control Console SW 9.2.18 was released to support the rol-out
10/18/2013;
Distribution of update instructions for TH017/13S and TH018/13S - Distribtuion of the Control Console SW 9.2.18 released
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
Siemen's issued a customer information letter under update instruction th016/12s to alert all its affected customers of the software issues. the software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
Acción
Siemens Medical Solutions sent a Customer Information letter via mail to all affected customers. The letter identified the affected product, problem and provide instructions on the correction. Customers were instructed to include the Customer Information letter in the Owner Manual chapter "Safety Advisory Letters".
9-16-13 UPDATE: - Control Console SW 9.2.18 was released to support the rol-out
10/18/2013;
Distribution of update instructions for TH017/13S and TH018/13S - Distribtuion of the Control Console SW 9.2.18 released
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
Siemen's issued a customer information letter under update instruction th016/12s to alert all its affected customers of the software issues. the software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
Acción
Siemens Medical Solutions sent a Customer Information letter via mail to all affected customers. The letter identified the affected product, problem and provide instructions on the correction. Customers were instructed to include the Customer Information letter in the Owner Manual chapter "Safety Advisory Letters".
9-16-13 UPDATE: - Control Console SW 9.2.18 was released to support the rol-out
10/18/2013;
Distribution of update instructions for TH017/13S and TH018/13S - Distribtuion of the Control Console SW 9.2.18 released
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
Glucose oxidase, glucose - Product Code CGA
Causa
Glucose test strips reports no result message when tested.
Acción
The firm, Nova Biomedical, sent an "Urgent Field Safety Notice 01-13SS" dated March 18, 2013 and US customers notification by phone contact and to the International customers including a Faxback Form to be communicated to and sent to Nova Biomedical Subsidiary by two methods of delivery (Email and Phone Call). The customers were instructed to INVALIDATE the Nova StatStrip Glucose Test Strip lots indicated in the list on all StatStrip meters within your institute; REPLACE all Nova StatStrip Glucose Test Strips from the indicated lots with replacement test strips provided by Nova; REMOVE all unused boxes of the Nova StatStrip Glucose Test Strip lots indicated from all locations within your institute; RETURN all unused boxes of the Nova StatStrip Glucose Test Strips lots indicated to Nova Biomedical U.K. or your local Nova distributor following the country specific instructions provided by your authorized Nova representative, and complete and return the Fax-Back Form via email or FAX to your Regional Service Manager at 781-8914806.
On April 08, 2013, the firm expanded the recall notification to include one additional test strip lot #0313021309 which was shipped under two catalog numbers(Catalog # 42214 and Catalog# 51493). US Notification by phone contact with key customer contact facilitated by Senior Manger of Technical Support Services. International - Field Safety Notice and Faxback Form is being communicated to and sent to Nova Biomedical Subsidiary by two methods of delivery (Email and Phone Call).
Questions regarding this notice should be directed to the following Nova Biomedical EU Authorized Representative at: Nova Biomedical Innovation House, Aston Lane South Runcorn,WA7 3FY Telephone: + 44 1244 287087
Email: Europe@novabiomedical.co.uk. or US at (781) 894-0800.
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 pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
Acción
Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the 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.
Vital images has made a decision to perform a field correction to the vitrea ct multi-chamber cardiac functional analysis application. vital images has identified a defect in which numerical values may be incorrect in the results table under the cardiac analysis portion of the user interface.
Acción
Vital Images sent an Urgent Field Safety Notice dated March 15, 2013, to all affected consignees. The letter described the problem and the product affected by the recall. Letter provided a series of steps to follow which included to cease use of the device and to send the signed enclosed Effectiveness Check form to fieldnotices@vitalimages.com or fax to 1-952-540-3717. For questions customers were instructed to call Customer Support at 1-800-208-3005.
For questions regarding this recall call 952-487-9500.
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, angiographic - Product Code IZI
Causa
In the course of the firm's product monitoring activities, a potential risk for patient or operators was determined during the operation of an artis zeego system with software revision vc14, vc20 and vc21 in conjunction with a specific technical configuration which cannot be completely executed.
Acción
Siemens sent an Urgent Customer Information letter dated November 8, 2012 to affected consignees. The letter notified consignees of the issue and informed them the update AX039/12/S would be started and affected systems would be checked and corrected if required. Customers were instructed that they would be contacted to arrange a date for checking their system.
For questions regarding this recall call 610-219-6300.
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
Wrap, sterilization - Product Code FRG
Causa
Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.
Acción
All US distributors and clinics were sent an Urgent: Voluntary Product Recall letter via Federal Express, and the Canadian importer/distributor was also notified with the same letter via Federal Express and e-mail. Distributors were instructed to contact their customers by sending a copy of the letter. The letter identified the affected product and stated the reason for the recall. The recall notification includes a Response Sheet that allows the customer (end-user) to indicate the quantity of affected product they have in their inventory or indicate whether they do not have any affected product. The customer is instructed to immediately cease further distribution of the product, physically quarantine and destroy the product, and fax the completed Response Sheet to the Kimberly-Clark Recall Coordinator.
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 pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
Acción
Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the 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.
The pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
Acción
Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the 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.
The pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
Acción
Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the 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.
The pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
Acción
Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the 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.
The pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
Acción
Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the 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.
The pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
Acción
Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the 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.
The pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
Acción
Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the 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.
The pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
Acción
Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the 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
Sterilizer, chemical - Product Code MLR
Causa
The recall was initiated because advanced sterilization products (asp) has determined that the sterrad 100nx and sterrad 200 sterilization systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
Acción
Advanced Sterilization Products sent an Urgent Medical Device Field Safety Notification letter dated March 22, 2013 to all customers. The letter identified the affected products, problem and actions to be taken. Customers are instructed to report any complaints or suspected problems with their STERRAD 100NX and/or STERRAD 200 System to ASP Professional Services directly at (888) 783-7723 and select option #2.
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
Sterilizer, chemical - Product Code MLR
Causa
The recall was initiated because advanced sterilization products (asp) has determined that the sterrad 100nx and sterrad 200 sterilization systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
Acción
Advanced Sterilization Products sent an Urgent Medical Device Field Safety Notification letter dated March 22, 2013 to all customers. The letter identified the affected products, problem and actions to be taken. Customers are instructed to report any complaints or suspected problems with their STERRAD 100NX and/or STERRAD 200 System to ASP Professional Services directly at (888) 783-7723 and select option #2.
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 pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
Acción
Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the 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.
The pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
Acción
Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the 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.
The pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
Acción
Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the 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.
The pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
Acción
Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the 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.
The pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
Acción
Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the 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.
Toshiba medical systems has received reports of startup issues with the toshiba tus-500 and
tus-300 ultrasound systems. the startup issue is predominant when attempting to bring the
system up from standby mode when the system is used remotely. it has been determined that this
may potentially cause damage to the system.
Acción
Toshiba sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated December 11, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (800) 421-1968 for questions regarding this 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.
Ge healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a ventri scanner. during a patient unload following a scan, the patients fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically.
Acción
Consignees were sent on 1/9/2013 a GE Healthcare "Urgent Medical Device Correction" letter dated January 9, 2013. The letter was addressed to Managers of Nuclear Medicine, Hospital Administrators / Risk Managers and
Managers of Radiology / Head of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information.