—#47766

Product

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 platform running the ApexPro Telemetry Application)

FDA product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K032369
Affected lot / code info: Software version 3.8 and earlier

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Ge Healthcare
Address: 9900 W Innovation Dr, Wauwatosa, Wisconsin 53226-4856

Distribution

Distribution pattern: 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, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerlant, Syria, Taiwan, Thailand, Tunisia, and Venezuela.

Timeline

Recall initiated: 2006-08-04
Posted by FDA: 2006-10-20
Terminated: 2012-07-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #47766. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.