FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Ultra Z 90 X-Ray Computed Tomography Scanners. These scanners were sold under the brand names: Picker, Marconi or Philips.
- Recall number
- Z-0957-05
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Ultra Z 90 X-Ray Computed Tomography Scanners. These scanners were sold under the brand names: Picker, Marconi or Philips.
- Status
- Terminated
- Initiated
- 2004-03-23
- Posted
- 2005-07-06
- Terminated
- 2012-03-02
- Reason
- 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
- Other
- Action
- 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.
- Quantity
- 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, GA, LA, MS, OH, NE, MO, IN, TN, TX, MI, NM, MA, AL and NH;
- Lot, serial or model codes
- All devices manufactured between January 1996 and June, 2004 were subject to recall.
- 510(k) numbers
- ["K955268"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- 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