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Recall Observatory FDA recall evidence

Device product

ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System

Z-1015-2015

December 16, 2014

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 70027
Status
Terminated
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-1015-2015

Official wording

Reason: Unqualified power assemblies shipped to customers.

Code information: 4P¿226813; 4P¿226815; 4P-226817; 4P-226818; 4P¿226819; 4P-226820; 4P-226821; 4P-226822

Distribution pattern: Distributed in OK and FL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Unqualified power assemblies shipped to customers.