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Terminated

Intellivue Information Center Model: M3150B#C01

FDA Recall Z-0596-03 · Posted 2003-02-28

Recalling FirmPhilips Medical Systems, Inc. Cardiac & Monitoring Systems
Recall StatusTerminated
Date Initiated2003-01-02
Date Terminated2006-02-15
Product Quantity39 units

Reason for Recall

Central Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Canada, Europe, Asia, Latin America

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011093AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154Agilent Technologies, Inc. · 2001-05-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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