FDA Medical Device Recalls (openFDA)
Philips Medical Systems, Inc. Cardiac & Monitoring Systems: Intellivue Information Center Model: M3150BU#CO1
- Recall number
- Z-0597-03
- Recalling firm
- Philips Medical Systems, Inc. Cardiac & Monitoring Systems
- Product
- Intellivue Information Center Model: M3150BU#CO1
- Status
- Terminated
- Initiated
- 2003-01-02
- Posted
- 2003-02-28
- Terminated
- 2006-02-15
- Reason
- Central Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up
- 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
- 7 units
- Distribution
- Nationwide Canada, Europe, Asia, Latin America
- Lot, serial or model codes
- 4225A00169 4225A00171 4225A00181 4225A00182 4213A13456 4131A13457
- 510(k) numbers
- ["K011093"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28