Recall Z-0014-2007 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Brilliance CT 40 Slice, Model #4550 110 04011. Brilliance CT Big Bore, Model #4535 670 88051. 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 | 20 |
| 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 |