Ultra Z 90 X-Ray Computed Tomography Scanners. These scanners were sold under the brand names: Picker, Marconi or Philip
FDA device recall Z-0957-05 · posted 2005-07-06 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Software anomaly in the DICOM Modality Worklist. When restoring a patient's images from the optical disk, images from the wrong patient may be displayed.
- Action taken
- The firm mailed a ''Product Safety Notification'', dated 3/23/2004, to all users who had DICOM Modality Worklist enabled with a software key. The customers were notified of the problem and were provided instructions as to how to prevent the anomaly from occurring. The notification also informed the users that updated software which corrects the anomaly will be available in the near future and will be installed by the firm''s Field Service Engineers.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 44
- Distribution
- Nationwide and Austria, Italy, Netherlands, Spain, United Kingdom, and Sweden. The units were installed in medical facilities located in the following states within the U.S.: KS, PA, FL, MN, IA, CA, G
- Date initiated
- 2004-03-23
- Date posted
- 2005-07-06
- Date terminated
- 2012-03-02
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM (K955268) | Philips Medical Systems (Cleveland), Inc. | 1996-01-30 |