Recall Z-0013-2007 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems.
| Date | Sep 26, 2007 (initiated Nov 6, 2006) |
| Status | Terminated |
| Reason | A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator. |
| Root cause | Other |
| Action | The customers were sent Public Safety Notification November 3, 2006, indicating there was a problem with the software. However, since their unit was recently upgraded the problem did not impact their unit. |
| Quantity | 70 |
| Distribution | Worldwide, including USA, Australia, Canada, China, England, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Netherlands, Poland, Puerto Rico, Spain, and Taiwan. |
| FDA record | Open on fda.gov |