Blood Pressure Module BPM3 TM-2917B — Class II medical device recall Z-3124-2024
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2024-09-18, distributed nationwide. Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005
| Recall number | Z-3124-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2024-08-08 |
| Classified | 2024-09-11 |
| Reported by FDA | 2024-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 3,718 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00840861100897, 00840861100903, 00840861100910, 00840861100927, 00840861100934, 00840861102082, 00840861102099, 00840861102105, 00840861102112 |
| Serial numbers | 00840861100903, 00840861100910, 00840861100927, 00840861100934, 00840861102082, 00840861102099, 00840861102105, 00840861102112, 190766, 190858, 190895, 190908, 191124, 191126, 191128, 191130, 4T0S275391, 4T0S275399, 4T0S275410, 4T0S275417, 4T0S275422, 4T0S275440, 4T0S275444, 4T0S275451, 4T0S275455 and 475 more |
| Model numbers | 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, 191130, 191378, 191389 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3124-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.