Viridia/Agilent Information Center Model : M3151A#CO1
FDA device recall Z-0595-03 · posted 2003-02-28 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc. Cardiac & Monitoring Systems
- Reason for recall
- Central Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up
- Action taken
- 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
- Status
- Terminated
- Quantity affected
- 82 units
- Distribution
- Nationwide Canada, Europe, Asia, Latin America
- Date initiated
- 2003-01-02
- Date posted
- 2003-02-28
- Date terminated
- 2006-02-15
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 (K011093) | Agilent Technologies, Inc. | 2001-05-01 |