—#50798

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.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K010817, K033326, K033357
Affected lot / code info: Serial #s 30035; 40022; 5059, 50027, 50017; 6011, 6095, 6118, 60006; 9145, 9036, 9115, 9089, 9042, 90061, 90109, 90072, 90050, 90150; 7022.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Road, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Worldwide, including USA, Australia, Canada, China, England, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Netherlands, Poland, Puerto Rico, Spain, and Taiwan.

Timeline

Recall initiated: 2006-11-06
Posted by FDA: 2007-09-26
Terminated: 2010-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50798. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.