Recall Z-2380-2012 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Zoe Medical Incorporated
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.
| Date | Sep 14, 2012 (initiated Jun 6, 2012) |
| Status | Terminated |
| Reason | Unit fails to power up, resulting in an equipment alarm |
| Root cause | Software design |
| Action | 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. |
| Quantity | 35 units |
| Distribution | Nationwide distribution: WA only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093802 | ULTRAVIEW DM3 MONITOR Zoe Medical, Inc., Apr 9, 2010 |