—#49169

Product

Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)

510(k) numbers: K033357
Affected lot / code info: Serial numbers 7009, 7056, 7060, 7066, 7069, 7072, 7079, 7088, 7111, 7112, 7113, 7114, 7117, 7118, 7119, 7121, 7125.

Why it was recalled

Two conditions have been identified with the Philips Medical System Brilliance Bore ,version 2.2.1 Tumor Localization, that may lead the user to misinterpret the displayed data.

Root cause (FDA determination)

Other

Action the firm took

Customer advisory notification letters dated 10/4/06 and 10/25/06 were sent to consignees providing short term work around instructions. Software modifications installed by the recalling firm will follow as the long term correction.

Recalling firm

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

Distribution

Distribution pattern: Class II Recall-Nationwide Distribution-USA including states of KY, MD, TX, RI, NJ, MA, LA, VA, PA, SC, CA, OH, and FL.

Timeline

Recall initiated: 2006-10-02
Posted by FDA: 2007-03-17
Terminated: 2012-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49169. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.