—#35728

Product

Ultra Z 90 X-Ray Computed Tomography Scanners. These scanners were sold under the brand names: Picker, Marconi or Philips.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K955268
Affected lot / code info: All devices manufactured between January 1996 and June, 2004 were subject to recall.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Road, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: 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, GA, LA, MS, OH, NE, MO, IN, TN, TX, MI, NM, MA, AL and NH;

Timeline

Recall initiated: 2004-03-23
Posted by FDA: 2005-07-06
Terminated: 2012-03-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #35728. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.