Class 2 Device Recall GEMINI TF16 Diagnostic Imaging System

• Date Initiated by Firm: May 31, 2011
• Date Posted: September 13, 2011
• Recall Status: Terminated on February 22, 2013
• Recall Number: Z-3199-2011
• Recall Event ID: 59175
• 510(K)Number: K052640
• Product Classification: System, tomography, computed, emission - Product Code JAK
• Product: Philips GEMINI TF16 Diagnostic Imaging Systems, Model Number: 882470, 510(k) #K052640, Serial Numbers: 7501, 7503, 7507, 7508, 7011, 7047, and 7174. The recalled GEMINI TF16 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine 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 CT AC. 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: The recalled system units are identified as follows: Model Number: 882470, and Serial Numbers: 7501, 7503, 7507, 7508, 7011, 7047, and 7174.
• 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: The firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur, it could impact the performance of reliability of the these PET/CT system units.
• FDA Determined Cause: Software design
• Action: The firm , Philips Healthcare, issued a 'Customer Information Letter' dated August 9, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were not required to perform any action. A Philips' Field Service Engineer will visit each customer site and install the necessary software upgrade and Philips will track the progress of the software corrections as they take place. For customers in North America, if you need any further information or support concerning this update, please contact our Customer Care Solutions Center at 1-800-722-9377. Selection option 5 for "All Imaging Systems". Enter your site ID number. If you do not know your site ID, please hold and then select option 5 for "Nuclear Medicine" and finally select option 2 for "PET" support. In all other countries, the local Philips Healthcare office should be contacted at 440-483-3000.
• Quantity in Commerce: 7 units were distributed.
• Distribution: Worldwide distribution: USA including states of: FL, MA, NE, NC, OH, TX, WA and WV; and countries of: France, Germany, Italy, Kuwait, The Netherlands, Spain and Turkey.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = JAK