FDA Device recall Z-3124-2024
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis…
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis… by Fresenius Medical Care Holdings, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3124-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-08 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
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.
Identifiers
| code_info | UDI-DI: 190573 NA 190713 00840861100897 (+ Serial Number) 190766 00840861100910 (+ Serial Number) 190858 00840861100903…UDI-DI: 190573 NA 190713 00840861100897 (+ Serial Number) 190766 00840861100910 (+ Serial Number) 190858 00840861100903 (+ Serial Number) 190895 00840861100927 (+ Serial Number) 190908 00840861100934 (+ Serial Number) 191124 00840861102082 (+ Serial Number) 191126 00840861102099 (+ Serial Number) 191128 00840861102105 (+ Serial Number) 191130 00840861102112 (+ Serial Number) Serial Numbers: 4T0S278166 4T0S278222 4T0S278232 4T0S278242 4T0S278353 4T0S278386 4T0S278395 4T0S278427 4T0S278445 4T0S278466 4T0S278471 4T0S278474 4T0S278477 4T0S278810 4T0S278824 4T0S278832 4T0S278835 4T0S278840 4T0S278841 4T0S278842 4T0S278845 4T0S278846 4T0S278847 4T0S278848 4T0S278851 4T0S278852 4T0S278859 4T0S278860 4T0S278862 4T0S275623 4T0S275627 4T0S275628 4T0S275629 4T0S275639 4T0S275649 4T0S275654 4T0S275662 4T0S275664 4T0S275666 4T0S275677 4T0S275682 4T0S275685 4T0S275688 4T0S275692 4T0S275703 4T0S275729 4T0S275738 4T0S275742 4T0S275745 4T0S275760 4T0S275768 4T0S275769 4T0S275778 4T0S275787 4T0S275800 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3124-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.