Recall Z-1418-05 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Gemini 16 PET/CT sytem, Slice Configuration
| Date | Aug 30, 2005 (initiated Mar 11, 2005) |
| Status | Terminated |
| Reason | When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect. |
| Root cause | Other |
| Action | The firm sent recall/field correction letters dated 3/11/05. |
| Distribution | The devices were distributed to consignees throughout the United States and to consigness located in Argentina, Austria, Bahama, Belarus, Belguim, Brazil, Canada, China, Chile, Columbia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, England, Finland, France, Greece, Germany, Hung |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032036 | GEMINI 16 Philips Medical Systems (Cleveland), Inc., Jul 11, 2003 |