Recall Z-1227-2009 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare
GE Healthcare ApexPro Telemetry System for mobile patient physiological monitoring.
| Date | Jun 1, 2009 (initiated Feb 24, 2009) |
| Status | Terminated |
| Reason | Intermittent or continuous loss of patient monitoring. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent on 2/20/09 a GE Healthcare "Urgent Medical Device Correction" letter dated 2/12/09. The letter was addressed to Risk Manger/Chief of Nursing/Director of Biomedical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. |
| Quantity | 291 |
| Distribution | Nationwide distribution and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032369 | MODIFICATION TO: APEXPRO TELEMETRY SYSTEM Ge Medical Systems Information Technologies, Aug 15, 2003 |