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.
This recall has been terminated (originally issued October 21, 2006).
- Company
- Ge Healthcare
- Recall Initiated
- June 23, 2006
- Posted
- October 21, 2006
- Terminated
- May 25, 2007
- Recall Number
- Z-0054-2007
- Quantity
- 379
- Firm Location
- Wauwatosa, WI
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Software versions v3.8 and earlier.
Root Cause
Other
Action Taken
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.