Company:Philips Medical Systems
Date of Enforcement Report 2/15/12
Class ll:
PRODUCT
GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1), a) Model # 882470 & GEMINI TF 64 PET/CT System (with software version 3.5.1 and 3.5.1.1), 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
REASON
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.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated December 5, 2011, Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
197 units
DISTRIBUTION
Nationwide and Internationally
