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U.S. Department of Health and Human Services

Class 2 Device Recall GEMINI TF Big Bore

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 Class 2 Device Recall GEMINI TF Big Boresee related information
Date Initiated by FirmAugust 05, 2009
Date PostedAugust 01, 2011
Recall Status1 Terminated 3 on September 21, 2012
Recall NumberZ-2915-2011
Recall Event ID 59210
510(K)NumberK081135 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductGEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476, Gantry S/N 9001-9023. The GEMINI TF Big Bore is a diagnostic imaging systems 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. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.
Code Information Catalogue #882476; Gantry S/N 9001-9023
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information Contact
440-483-7000
Manufacturer Reason
for Recall		Two non-safety related defects have been found on the Philips GEMINI TF Big Bore running version 3.6; if these defects were to recur, it could impact the performance or reliability of the system. Philips is issuing a software update to all Philips GEMINI TF Big Bore customers to correct these defects.
FDA Determined
Cause 2		Software design (manufacturing process)
ActionPhilips Medical Systems (Cleveland) Inc. sent an "GEMINI TF BIG BORE CPE CUSTOMER LETTER" dated October 20, 2011 to all affected customers. The letter describes the product, problem, and updates that are available to the customers. The letter provides additional information about acquisition workflows for SUV Calibrations and Validations. For support concerning this upgrade, contact the Customer Care Solutions Center at 1-800-722-9377.
Quantity in Commerce23 units
DistributionWorldwide Distribution-USA (nationwide) including the states of CO, LA, MD, MI, MO, MN, PA, TX, VA, VT and WI and the countries of Belgium, Germany, Italy, Saudi Arabia and Switzerland.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KPS
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