Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care pro
FDA device recall Z-2380-2012 · posted 2012-09-14 · Terminated
Recall details
- Recalling firm
- Zoe Medical Incorporated
- Reason for recall
- Unit fails to power up, resulting in an equipment alarm
- Action taken
- The firm, Zoe Medical, coordinated with the Distributor via email on June 7, 2012. The email described the product, problem and actions to be taken. Zoe will remove product the site and return the units for correction. If you have any questions, contact Manager, Global Technical Support at 425-657-7200 ext 5508.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 35 units
- Distribution
- Nationwide distribution: WA only.
- Date initiated
- 2012-06-06
- Date posted
- 2012-09-14
- Date terminated
- 2012-09-18
- Location
- Topsfield, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRAVIEW DM3 MONITOR (K093802) | Zoe Medical, Inc. | 2010-04-09 |