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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Medical Systems GEMINI TF 16 PET/CT System &38; GEMINI TF 64 PET/CT System

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 Class 2 Recall
Philips Medical Systems GEMINI TF 16 PET/CT System &38; GEMINI TF 64 PET/CT System
see related information
Date Posted February 02, 2012
Recall Status1 Terminated on June 18, 2013
Recall Number Z-0937-2012
Recall Event ID 60969
Premarket Notification
510(K) Number
K052640 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product GEMINI TF 16 PET/CT System & GEMINI TF 64 PET/CT System, 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, head, 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. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium.
Code Information GEMINI TF 16 Serial Number 7224 & GEMINI TF 64 Serial Number 7217
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Philips became aware of an issue relating to a UPS cabinet that contained a melted battery which caused damage to other batteries lower in the cabinet, leading to battery acid leaking on the floor.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
Action Philips Medical Systems (Cleveland) Inc communitcated the problem to the facilities via telephone. No customer letter was sent since the correction was already performed by the supplier.
Quantity in Commerce 2
Distribution Nationwide Distribution including Maryland and Colorado
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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