Fresenius Medical Care Holdings, Inc.: 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

Agency Publication Date: April 20, 2020

Affected Products

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

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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

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85310

Status: Active

Manufacturer: Fresenius Medical Care Holdings, Inc.

Manufactured In: United States

Units Affected: 2 products (101,463; 15,342)

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Sources: FDA iRES · Raw API Response

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Affected Products

All serial numbers