FDA Medical Device Recalls (openFDA)
Philips Medical Systems, Inc. Cardiac & Monitoring Systems: Intellivue Information Center Model: M3150B#C01
- Recall number
- Z-0596-03
- Recalling firm
- Philips Medical Systems, Inc. Cardiac & Monitoring Systems
- Product
- Intellivue Information Center Model: M3150B#C01
- 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
- 39 units
- Distribution
- Nationwide Canada, Europe, Asia, Latin America
- Lot, serial or model codes
- Serial 4225A00106 4225A00107 4225A00108 4225A00111 4225A00112 4225A00113 4225A00114 4225A00116 4225A00117 4225A00118 4225A00119 4225A00127 4225A00145 4225A00149 4225A00150 4225A00151 4225A00152 4225A00164 4225A00165 4225A00166 4225A00167 4225A00169 4225A00188 4225A00189 4213A13698 4213A13700 4225A00122 4225A00136 4225A00138 4225A00137 4225A00139 4225A00140 4225A00142 4225A00143 4225A00144 4225A00101 4225A00102 4225A00103 4225A00104
- 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