Recall – Hemodialysis system may incorrectly display alarm

Company: Fresenius Medical Care Holdings, Inc.
Date of Enforcement Report: 4/29/2020
Class II

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

Recall Number: Z-1748-2020

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.

RECALLING FIRM/MANUFACTURER

Fresenius Medical Care Holdings, Inc. on 3/12/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

101,463

DISTRIBUTION

US Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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