—#82414

Product

TumorLoc Software Application, Software versions: 23.1.1, 20.7.13, and 20.8.15. This is an option available for purchase for use on the GEMINI GXL 16 Slice PET/CT System (contains EBW 455011002031 as an accessory), Catalog #882410, Model Number: 4535 679 71891. CT host. 2.2. Tumor Localization is an application used in radiation oncology departments for localizing target volumes for radiation therapy planning. It includes exclusive features for viewing Respiratory Correlated CT data sets and analyzing motion of target and surrounding anatomy.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K051170
Affected lot / code info: GEMINI GXL 16 Slice - Serial Numbers: 4149, 4150, and 4173.

Why it was recalled

A software anomaly in the TumorLoc software for the firm's Brilliance CT scanners was discovered. The same software anomaly was subsequently determined to be present in the firm's GEMINI PET/CT units. The software defect results in a the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.

Root cause (FDA determination)

Software design

Action the firm took

An "URGENT - Field Safety Notice" dated February 12, 2009 was sent via FedEx to domestic customers. The notice described the affected products, issue, involved hazard should problem occur and corrective actions for the customer/user. The letter also notified users/customers that a Philips Healthcare Field Service Engineer will contact and visit their site within 6 months to install a TumorLoc upgrade. Notification will also be sent to the international consignees by Philips personnel. For further information or support concerning this issue, please contact your local Philips representative: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology) or to your local Philips Healthcare office.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- US, Columbia, Germany, France, Netherlands, Canada, Belgium and Slovenia.

Timeline

Recall initiated: 2009-02-19
Posted by FDA: 2009-07-06
Terminated: 2012-09-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82414. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.