B105P — Class II medical device recall Z-0455-2026
Ongoing recall by GE Healthcare Finland Oy, reported 2025-11-19, distributed nationwide. Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lo
| Recall number | Z-0455-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare Finland Oy, Helsinki, Finland |
| Recall initiated | 2025-09-26 |
| Classified | 2025-11-07 |
| Reported by FDA | 2025-11-19 |
| Distributed | Nationwide (US) |
| Quantity | 7,408 |
| UPC / GTIN / UDI-DI | 00195278488473, 00195278489760, 00195278489845, 00195278489883, 00195278490223, 00195278490230, 00195278490247, 00195278490254, 00195278561466, 00195278561510, 00195278562050, 00195278562074, 00195278562098, 00195278562104, 00195278562111, 00195278611451, 00840682146708, 00840682146715, 00840682146791, 00840682147224 |
| Serial numbers | 0188WA, 25250362PA, SR525270031WA, SR525270032WA, SR525270033WA, SR525270034WA, SR525270035WA, SR525270036WA, SR525270037WA, SR525270038WA, SR525270039WA, SR525270040WA, SR525270041WA, SR525270042WA, SR525270043WA, SR525270044WA, SR525270045WA, SR525270046WA, SR525270047WA, SR525270048WA, SR525270049WA, SR525270050WA, SR525270051WA, SR525270052WA, SR525270053WA and 475 more |
| Model numbers | 6160000-002, 6160000-003, 6160000-004, 6160000-005, 6160000-101, 6160000-102, 6160000-103, 6160000-104, 6160000-105, 6160001-063, 6160001-064, 6160001-065 |
Product
B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102 6160000-103 6160000-104 6160000-105 6160001-063 6160001-064 6160001-065 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms 3/19/26 updated to add B105P Patient Monitor 6160001-061 B125P Patient Monitor 6160001-062 B105M-C Patient Monitor 6160002-033 B105M-A Patient Monitor 6160000-113 B155M-A Patient Monitor 6160000-115 B125P-B Patient Monitor 6160002-022 B105M-B Patient Monitor 6160002-023 B125M-B Patient Monitor 6160002-024 B105M-OR Patient Monitor 6160000-143 B105M-OR Patient Monitor 6160000-144 B155M-OR Patient Monitor 6160000-145
Reason for recall
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
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-0455-2026. 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.