Fresenius Medical Care Holdings, Inc. recalls Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008…
- Recall date
- August 8, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3124-2024
- FDA classification
- Class II
- Brand / firm
- Fresenius Medical Care Holdings, Inc.
- Sold / distributed
- US Nationwide. Canada.
Why it was recalled
Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
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