Class II — Zoe Medical Incorporated
| Recalling firm | Zoe Medical, Inc |
|---|---|
| Registered facility | ZOE MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Unit fails to power up, resulting in an equipment alarm |
| 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. |
| Quantity | 35 units |
| Distribution | Nationwide distribution: WA only. |
| Initiated | 2012-06-06 |
| Classified | 2012-09-14 |
| Terminated | 2012-09-18 |
| Recall number | Z-2380-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Zoe Medical Incorporated (Z-2380-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62939/
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