Recall archive / FDA device enforcement
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330 — FDA record Z-3098-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 13, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Zoe Medical Incorporated
- Quantity
- 6429 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3098-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model No. 91330; no UDI-DI (distributed prior to UDI regulation); all serial numbers up to FFD8292 Model No. 91330; no UDI-DI (distributed prior to UDI regulation); all serial numbers up to FFD8292 Model No. 91330; no UDI-DI (distributed prior to UDI regulation); all serial numbers up to FFD8292 Model No. 91330-M; UDI-DI 00851920007002; all serial numbers up to FFD8292 Model No. 91330-MT; UDI-DI 00851920007019; all serial numbers up to FFD8292 Model No. 91330-N; UDI-DI 00851920007026; all serial numbers up to FFD8292 Model No. 91330-NT; UDI-DI 00851920007033; all serial numbers up to FFD8292 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
awaiting additional details
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 18, 2024
- Recall initiation date
- Aug 13, 2024
- Center classification date
- Sep 10, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.