Device product
Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K
Z-1619-2014
Product summary
- Event
- Event 68042
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39 units
- Official record key
device-enforcement:Z-1619-2014
Official wording
Reason: 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
Code information: Revision K Actuator Test Boards
Distribution pattern: USA (nationwide) and the country of Canada.*
Derived failure modes
-
Unknown
2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump