Z-0659-2017 Class I Terminated
FDA device recall Z-0659-2017 was initiated by SynCardia Systems Inc. on October 21, 2016 and is designated Class I. Reason for recall: The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without visual or audible alarms, resulting in the loss of life… The recall status is terminated (terminated February 21, 2017). Affected quantity: 5.
Recall Details
- Product Type
- Devices
- Report Date
- December 14, 2016
- Initiation Date
- October 21, 2016
- Termination Date
- February 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product Description
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
Reason for Recall
The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without visual or audible alarms, resulting in the loss of life-sustaining function.
Distribution Pattern
US distribution to Virginia and Arizona.
Code Information
S/N 5002 UDI (01)00858000003121(21)5002 S/N 5005 UDI (01)00858000003121(21)5005 S/N 5008 UDI (01)00858000003121(21)5008 S/N 5009 UDI (01)00858000003121(21)5009 S/N 5010 UDI (01)00858000003121(21)5010