Z-0054-2007

ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn...

Name: Z-0054-2007 ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn...
Creator: Ge Healthcare
Published: 2006-06-23
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-06-23 / Terminated

FDA source

Ge Healthcare began a recall of ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data... on 2006-06-23. The reason FDA records is "System Warning Alarm failure: When a patient being monitored 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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0054-2007
Status: Terminated
Initiated: 2006-06-23
Posted: 2006-10-21
Terminated: 2007-05-25
Recalling firm: GE Healthcare
Product: ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data acquisition transceivers, the transceiver access points with antenna, the network infrastructure, A computer platform running the ApexPro Telemetry Application and a computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application). GE Medical Systems information Technologies, 8200 West Tower Avenue, Milwaukee, WI 53223.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: System Warning Alarm failure: When a patient being monitored 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 does not occur.
FDA root cause: Other
Action: An Urgent Medical Device Correction letter, dated June 23, 2006, was sent to customers notifying them of the issue, provided short term recommendations and provided the long term solution as a software upgrade that will correct this situation. A reply card is asked to be returned to initiate the upgrade process.
Quantity in commerce: 379
Distribution: Nationwide distribution --- including states of AL, AR, AZ, CA, CO, Washington DC, FL, IL, IN, ME, MI, MN, MO, NC, NE, NJ, NY, OK, PA, SC, TX, VA, WA, WI, WV.
Product codes and lots: Software versions v3.8 and earlier.

Product code MHX

K033365Class IIApexpro Fh Telemetry SystemGe Medical Systems Information Technologies / cleared 2003-11-06

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)