Z-1029-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 25, 2017
- Initiation Date
- December 21, 2016
- Termination Date
- March 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1400 units (US) 556 units (OUS)
Product Description
Fresenius 2008K@home Series : Hemodialysis System
Reason for Recall
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
Distribution Pattern
Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam
Code Information
All serial numbers