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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
Serial #s 30035, 40022, 5059, 50027, 50017, 6011, 6095, 6118, 60006, 9145, 9036, 9115, 9089, 9042, 90061, 90109, 90072, 90050, 90150, 7022.
Products Sold
Serial #s 30035; 40022; 5059, 50027, 50017; 6011, 6095, 6118, 60006; 9145, 9036, 9115, 9089, 9042, 90061, 90109, 90072, 90050, 90150; 7022.
Philips Medical Systems (Cleveland) Inc is recalling Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. due to A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026