Company:Philips Medical Systems
Date of Enforcement Report 2/15/12
GEMINI TF 16 PET/CT System (with software version 3.5.1 and 188.8.131.52), a) Model # 882470 & GEMINI TF 64 PET/CT System (with software version 3.5.1 and 184.108.40.206), b) Model #882471. The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Recall # Z-0805-2012
Philips received notification by a customer of an issue relating to unwanted auto delete occurrences resulting in raw data being deleted and, in some cases, raw data being deleted immediately after scan acquisition but before images are reconstructed.
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated December 5, 2011, Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally