Recall Z-0054-2007 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Ge Healthcare
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
| Date | Oct 21, 2006 (initiated Jun 23, 2006) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033365 | APEXPRO FH TELEMETRY SYSTEM Ge Medical Systems Information Technologies, Nov 6, 2003 |