Recall Z-0055-2007 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Ge Healthcare
GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -The patient worn data acquisition transmitters; -The receiver antenna system infrastructure; -The receivers; -The receiver subsystem; -A computer platform running the Apex Pro Telemetry Application; -A computer platform running a central station application (which may be the same computer platfo
| Date | Oct 20, 2006 (initiated Aug 4, 2006) |
| Status | Terminated |
| Reason | When a patient being monitored with ApexPro/Apex Pro CH Telemetry with ST monitoring disabled is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border around the patient panel at the CIC (Clinical Information Center) does not occur. |
| Root cause | Other |
| Action | An Urgent Medical Device Correction letter dated August 04, 2006 was sent to customers with affected devices. The letter described the issue affecting devices containing software versions v3.8 and earlier, provides short term recommendations and a long term solution of updating the software. |
| Quantity | 5,203 |
| Distribution | Worldwide-USA and Puerto Rico and countries of ,Australia, Belgium, Canada, China, Croatia, Czech Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Guam, Honduras, Hong Kong, Hunary, India, Indonesia, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Malaysia, Malta, Mexico, Netherla |
| 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 |