Recall Z-0835-03 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Philips MX8000 IDT CT Scanner, utilizing V2.1 software.
| Date | May 15, 2003 (initiated Apr 2, 2003) |
| Status | Terminated |
| Reason | Patient images may be incorrectly stored in the archive directory of a different patient. |
| Root cause | Other |
| Action | The firm mailed a ''Product Safety Notification'', dated 4/2/2003, to all affected user sites. |
| Quantity | 137 installed units (59 domestic) |
| Distribution | The units were installed in medical facilities located nationwide, and in the following foreign countries: China, Belgium, France, Austria, Germany, Italy, Netherlands, Australia, Israel, Spain, Denmark, Singapore, Switzerland, Russia, South Korea, Canada, United Kingdom, South Africa, Sweden, Japa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012009 | MX8000 IDT CT SYSTEM Marconi Medical Systems, Inc., Sep 13, 2001 |