—#111947

Product

Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH. 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. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: " The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders. " The detection, localization, and staging of tumors and diagnosing cancer patients. " Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of with regional cerebral activity from PET images.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K051170, K052640, K081135
Affected lot / code info: GEMINI TF 16 System serial numbers: 7194, 7186, 7235, 7233 GEMINI GXL 16 System serial number: 4201 GEMINI TF Big Bore System serial numbers: 9022, 9201

Why it was recalled

Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a hole through the casing on one of the batteries. Supplier of the UPS, Chloride/Emerson, determined the batteries, housed within the UPS battery cabinet, entered thermal runaway causing the battery to overheat.

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated August 8, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Field Service Engineers will be implementing a Field Change Order (FCO) to replace the batteries of the affected UPS units. Contact the Philips Healthcare Customer Care Solutions Center at 1-800-722-9377 for questions regarding this notice. .

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution-including the states of CO, FL, MD, MN, NE and PA.

Timeline

Recall initiated: 2012-08-08
Posted by FDA: 2012-08-22
Terminated: 2014-04-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111947. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.