Recall Z-3124-2024— Fresenius Medical Care Holdings, Inc.
Class II · Ongoing
Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2024-08-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-08
- Firm location
- Waltham, MA, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.