Company: Philips Medical Systems
Date of Enforcement Report 7/29/2009
Class:ll
PRODUCT
1) TumorLoc software application, Software Versions: 23.1.1, 20.7.13, and 20.8.15 for use on the GEMINI TF 16 and GEMINI TF 64 Slice PET/CT Systems, Catalog Numbers: 882470 – GEMINI TF 16 Slice; 882471 – GEMINI TF 64 Slice; and 882473 – GEMINI TF 16 Slice Base Configuration. Model Numbers: 4535 679 83931 – GEMINI TF 16 Slice; 4535 679 94741 – GEMINI TF-64 Slice and 4535 674 41711 – GEMINI TF 16 Slice Base Configuration. 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. Recall # Z-1578-2009;
2) 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. Recall # Z-1579-2009;
3) TumorLoc Software Application for the EBW (Extended Brilliance Workstation, Model # 455011002031, sold as an accessory for the GEMINI PET/CT Systems running CT software versions 3.5.x. , 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
REASON
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 potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated February 14, 2009.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
Nationwide and Columbia, Germany, France, Netherlands, Canada, Belgium and Slovenia
