Agency classClass IIOur severity:High FDA (Devices)·Z-0734-2023·Announced 2022-12-28

Fresenius 2008T Hemodialysis Machines Recalled for False USB Device Alarm

Fresenius Medical Care is recalling 2008T and 2008T Bluestar Hemodialysis Machines with CDX due to a software and hardware sensitivity to electromagnetic interference that triggers false alarms.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a medical device used for life-critical dialysis therapy. Although the issue is an electromagnetic-interference-triggered false alarm with no reported injuries, illnesses, or hospitalizations in the source text, hemodialysis machines are high-risk devices and false alarms on such systems pose potential risk of harm.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling 2008T and 2008T Bluestar Hemodialysis Machines equipped with CDX technology. These machines are used for acute and chronic dialysis therapy in healthcare facilities.

The recall was initiated due to a software and hardware issue affecting the UI-MICs Board. The board is sensitive to electromagnetic interference, which causes the machine to display a false alarm stating "Remove USB 2 Device." The affected software versions are 2.72 and earlier. Approximately 70,552 units of the 2008T with CDX and 25,205 units of the 2008T Bluestar with CDX are affected nationwide.

Healthcare facilities using affected machines should contact Fresenius Medical Care Holdings, Inc. or the FDA for guidance on software updates and instructions for addressing this issue.

The recalled product

Product: 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124…
Manufacturer: Fresenius Medical Care Holdings, Inc.
Category: Medical Device — Hemodialysis
Hazard: electromagnetic-interference
false-alarm

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

Software issue in SW versions 2.72 and earlier with CDX. UDI: (1) 00840861100897
(2) 00840861100910
(3) 00840861102082
(4) 00840861102099

Distribution

Distributed nationwide across the United States.

Same manufacturer · Fresenius Medical Care Holdings, Inc.

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Same hazard · electromagnetic interference