Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview… — Class II medical device recall Z-2380-2012
Terminated recall by Zoe Medical Incorporated, reported 2012-09-26, distributed nationwide. Unit fails to power up, resulting in an equipment alarm
| Recall number | Z-2380-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zoe Medical Incorporated, Topsfield, MA, United States |
| Recall initiated | 2012-06-06 |
| Classified | 2012-09-14 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2012-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 35 units |
| Serial numbers | FFD3291, FFD3292, FFD3293, FFD3294, FFD3295, FFD3296, FFD3297, FFD3298, FFD3299, FFD3300, FFD3301, FFD3302, FFD3303, FFD3304, FFD3306, FFD3307, FFD3308, FFD3309, FFD3310, FFD3312, FFD3313, FFD3314, FFD3315, FFD3316, FFD3317 and 10 more |
| Model numbers | 91330-NT |
Product
Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.
Reason for recall
Unit fails to power up, resulting in an equipment alarm
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-2380-2012. 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.