FDA Recall
Terminated
Intellivue Information Center Model: M3150B#C01
Recall: Z-0596-03
·
Initiated January 2, 2003
Recall
- Recall Number
- Z-0596-03
- Event Number
- 25430
- Firm
- Philips Medical Systems, Inc. Cardiac & Monitoring Systems
- FEI Number
- 1218950
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 2, 2003
- Posted
- February 28, 2003
- Terminated
- February 15, 2006
- Address
- 3000 Minuteman Road, Andover, MA, 01810
Description
Intellivue Information Center Model: M3150B#C01
Reason
Central Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up
Action
Philips Medical Systems notified users by Certified Mail on/about 2/19/03 that the firm was initiating a device field correction (recall) to conduct an upgrade to units witha HP VL400 or VL420 computer which is cconfigured for dual display by replacing the video and network communication card. Previous to this notification, Philips sent letters on 1/2/03 addressed to Biomedical Engineering Manager to advise users to reboot the system in the event of a system freeze.
Distribution
Nationwide Canada, Europe, Asia, Latin America
Quantity
39 units