Device product

Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR

Z-1749-2020

March 12, 2020

Class II

Product summary

Firm: Fresenius Medical Care Holdings, Inc.
Event: Event 85310
Status: Ongoing
Classification: Class II
Quantity: 15,342
Official record key: device-enforcement:Z-1749-2020

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