Recall Z-0958-05 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
AcQSim X-Ray Computed Tomography Scanners. These scanners were sold under the brand names: Picker, Marconi or Philips.
| Date | Jul 6, 2005 (initiated Mar 23, 2004) |
| Status | Terminated |
| 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; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001088 | ULTRASIM CT SYSTEM Philips Medical Systems (Cleveland), Inc., Jun 22, 2000 |