Carescape B450 — Class II medical device recall Z-0453-2026
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-0453-2026 |
|---|---|
| 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 | 3,271 |
| UPC / GTIN / UDI-DI | 00840682105224, 00840682142045, 00840682142380, 00840682146135 |
| Serial numbers | 2068491-002, 2094080-001, 2107633-001, SJA14159926HA, SJA14291675HA, SNE17480314HA, SNE18130202HA, SNE18270096HA, SNT21350014HA, SNT23200068HA, SNT23200084HA, SNT23240036HA, SNT23240042HA, SNT24206004SA, SNT24206015SA, SNT24206022SA, SNT24206039SA, SNT24206041SA, SNT24206047SA, SNT24206057SA, SNT24206077SA, SNT24408968SA, SNT24408978SA, SNT24408979SA, SNT24408983SA and 475 more |
| Model numbers | 2068491-002, 5805686 |
Product
Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Record updated 3/19/26 to include: CARESCAPE B450 MBA313 2095800-001 CARESCAPE MONITOR B450 (ATO MODEL) 2068491-002 CARESCAPE MONITOR B450 B1 2107633-001 CARESCAPE MONITOR B450-GS (V2.0.8) 2094080-001
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-0453-2026. 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.