Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0597-03

Intellivue Information Center Model: M3150BU#CO1

Philips North America LLC / initiated 2003-01-02 / Terminated

Philips Medical Systems, Inc. Cardiac & Monitoring Systems began a recall of Intellivue Information Center Model: M3150BU#CO1 on . The reason FDA records is "Central Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0597-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
Intellivue Information Center Model: M3150BU#CO1
Reason for recall
Central Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up
FDA root cause
Other
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.
Quantity in commerce
7 units
Distribution
Nationwide Canada, Europe, Asia, Latin America
Product codes and lots
4225A00169 4225A00171 4225A00181 4225A00182 4213A13456 4131A13457