CARESCAPE Canvas Smart Display — Class II medical device recall Z-2169-2024
Ongoing recall by GE Healthcare Finland Oy, reported 2024-07-03. GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Can
| Recall number | Z-2169-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare Finland Oy, Helsinki, Finland |
| Recall initiated | 2024-04-05 |
| Classified | 2024-06-21 |
| Reported by FDA | 2024-07-03 |
| Quantity | 4,649 units |
| UPC / GTIN / UDI-DI | 00195278522313 |
| Serial numbers | 2494372-1-1, 2494479-1-1, 2494483-1-1, 2494484-1-1, 2494485-1-1, 2494487-1-1, 2494497-1-1, 2494500-1-1, 2494525-1-1, 2494526-1-1, 2494648-5-1, 2495264-1-1, 2495298-1-1, 2495299-1-1, 2495358-1-1, 2495361-1-1, 2495362-1-1, 2495388-2-1, 2495390-1-1, 2495390-1-2, 2495390-1-3, 2495390-1-4, 2495391-1-1, 2495391-1-2, 2495391-1-3 and 475 more |
Product
CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
Reason for recall
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.
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-2169-2024. 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.