Spacelabs Ultraview DM4 Vital Signs Monitor — Class II medical device recall Z-3099-2024
Ongoing recall by Zoe Medical Incorporated, reported 2024-09-18. This product labeling does not adequately provide warning about the risks associated with the use of damaged b
| Recall number | Z-3099-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zoe Medical Incorporated, Topsfield, MA, United States |
| Recall initiated | 2024-08-13 |
| Classified | 2024-09-10 |
| Reported by FDA | 2024-09-18 |
| Quantity | 1,506 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00851920007309, 00851920007316, 00851920007323, 00851920007330, 00851920007347, 00851920007354, 00851920007361, 00851920007378 |
| Serial numbers | GFD10486 |
| Model numbers | 91331, 91331-M, 91331-MF, 91331-MFW, 91331-MW, 91331-N, 91331-NF, 91331-NFW, 91331-NW |
Product
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
Reason for recall
This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.
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-3099-2024. 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.