| Date Initiated by Firm | January 02, 2003 |
|---|
| Date Posted | February 28, 2003 |
|---|
| Recall Status1 |
Terminated 3 on February 15, 2006 |
| Recall Number | Z-0597-03 |
|---|
| Recall Event ID |
25430 |
| 510(K)Number | K011093 |
|---|
| Product | Intellivue Information Center
Model: M3150BU#CO1 |
|---|
| Code Information |
4225A00169 4225A00171 4225A00181 4225A00182 4213A13456 4131A13457 |
| FEI Number |
1218950
|
Recalling Firm/
Manufacturer |
Philips Medical Systems, Inc. Cardiac & Monitoring Systems
3000 Minuteman Road
Andover MA 01810
|
| For Additional Information Contact | Brenda Getchell
978-659-2134 |
|---|
Manufacturer Reason
for Recall | Central Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up |
|---|
FDA Determined
Cause 2 | 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 |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code =
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