—#46967

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.

FDA product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K033365
Affected lot / code info: Software versions v3.8 and earlier.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2006-06-23
Posted by FDA: 2006-10-21
Terminated: 2007-05-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #46967. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.