—#64580

Product

The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033357
Affected lot / code info: All Brilliance CT Big Bore Scanners with Tumor Localization software versions v2.2.1, v2.2.2, & v2.2.5. This software version is included on Brilliance CT Big Bore Scanners, Model Number 728243, and Serial Numbers 7001 - 7215.

Why it was recalled

The maximum intensity projection (MIP) images produced from respiratory gated images by the Tumor Localization (Tumor LOC) software application on Brilliance Big Bore CT scanners will be labeled incorrectly for certain patient orientations and view conventions when saved for later viewing.

Root cause (FDA determination)

Software design

Action the firm took

Notification letters were sent to the installed customer base informing them of the hazard on 10/1/2007. A mandatory corrective software release due out mid October 2007, will be available at no cost to the customer. The software will be installed by Philips Field Service Engineers.

Recalling firm

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

Distribution

Distribution pattern: Worldwide, including USA, Canada, France, Finland, Korea, Australia, Italy, Switzerland, China, Austria, Thailand, Malaysia, Denmark, Norway, Jordan, Netherlands, England, South Africa, Spain, Germany, Bahrain, Belgium, New Zealand, Puerto Rico, South Korea, Saudi Arabia, Czech Republic, Sweden, Israel, and Lithuania

Timeline

Recall initiated: 2007-09-27
Posted by FDA: 2007-11-07
Terminated: 2012-03-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64580. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.