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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
ApexPro Telemetry System		see related information
Date Posted October 20, 2006
Recall Number Z-0055-2007
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)
Code Information Software version 3.8 and earlier
Recalling Firm/
Manufacturer		 Ge Healthcare
9900 W Innovation Dr
Wauwatosa, Wisconsin 53226-4856
Reason for
Recall		 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.
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 in Commerce 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, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerlant, Syria, Taiwan, Thailand, Tunisia, and Venezuela.
 
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