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Recall Observatory FDA recall evidence

Device product

Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD System With CDX, CAN

Z-1748-2020

March 12, 2020

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 85310
Status
Ongoing
Classification
Class II
Quantity
101,463
Official record key
device-enforcement:Z-1748-2020

Official wording

Reason: A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine

Code information: All serial numbers

Distribution pattern: Nationwide Foreign: Canada, Curaca, Guam

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine