Company:Philips Medical Systems Inc.
Date of Enforcement Report 3/6/2013
Class ll:
PRODUCT
Philips Medical Systems, GEMINI LXL – Model #882412; GEMINI TF 16 – Model #882470 and Model #882473; GEMINI TF 64 – Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Recall Number Z-0882-2013
REASON
Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are ‘flipped’ and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Projection data set is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Inc., Cleveland, OH on 10/24/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
Nationwide and Internationally
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