Z-0055-2007

GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -The patient...

Name: Z-0055-2007 GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -The patient...
Creator: Ge Healthcare
Published: 2006-08-04
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-08-04 / Terminated

FDA source

Ge Healthcare began a recall of GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -The patient worn data acquisition transmitters; -The receiver... on 2006-08-04. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0055-2007
Status: Terminated
Initiated: 2006-08-04
Posted: 2006-10-20
Terminated: 2012-07-03
Recalling firm: GE Healthcare
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)
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
FDA 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 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.
Product codes and lots: Software version 3.8 and earlier

Product code MHX

K032369Class IIModification to: Apexpro Telemetry SystemGe Medical Systems Information Technologies / cleared 2003-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)