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U.S. Department of Health and Human Services

Class 2 Device Recall Gemini TF 16 and Gemini TF 64 PET/CT Systems Software Versions 3.5.1 and 3.5.1.1

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 Class 2 Recall
Gemini TF 16 and Gemini TF 64 PET/CT Systems Software Versions 3.5.1 and 3.5.1.1
see related information
Date Posted January 18, 2012
Recall Status1 Terminated on February 22, 2013
Recall Number Z-0805-2012
Recall Event ID 60933
Premarket Notification
510(K) Number
K052640 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model # 882470 & GEMINI TF 64 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model #882471 Philips Medical Systems, Highland Heights, 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.
Code Information Product Code 882470, Seriel #'s: 7003-7006, 7008-7011, 7014, 7015, 7017-7026, 7031, 7034-7036, 7039, 7041, 7043, 7045, 7047, 7049, 7050-7054, 7058, 7060, 7062, 7064, 7066, 7068, 7069, 7073-7075, 7077, 7080, 7081, 7084-7087, 7089, 7093-7099, 7104, 7106-7108, 7112, 7114, 7115, 7118, 7120-7123, 7125, 7128, 7129, 7131, 7133, 7135, 7137-7140, 7142, 7143, 7145, 7147, 7148, 7156, 7159, 7161, 7163, 7165, 7166, 7168, 7170, 7173, 7174, 7176, 7177, 7181, 7183-187, 7193-7200, 7205, 7208, 7210, 7211, 7215, 7216, 7220, 7223 & 7224. Product Code 882471, Seriel #'s: 7007, 7012, 7013, 7016, 7027-7030, 7032, 7042, 7044, 7055, 7057, 7059, 7061, 7063, 7065, 7067, 7071, 7072, 7076, 7078, 7079, 7082, 7083, 7088, 7091, 7092, 7102, 7103, 7105, 7109, 7110, 7116, 7117, 7119, 7126, 7132, 7136, 7141, 7144, 7146, 7149, 7152-7154, 7158, 7160, 7164, 7167, 7169, 7171, 7172, 7175, 7178-7180, 7182, 7188-7190, 7192, 7201-7204, 7206, 7209, 7212-7214, 7217-7219 & 7221.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
Manufacturer Reason
for Recall
Philips received notification by a customer of an issue relating to unwanted auto delete occurrences resulting in raw data being deleted and, in some cases, raw data being deleted immediately after scan acquisition but before images are reconstructed.
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips Medical System sent a Urgent Medical Device Correction letter dated December 5, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The following are recommended actions: 1. Please ask your local Philips Service Engineer to ensure that the Auto Delete function is configured to run automatically. 2. Please share this information with all Philips GEMINI TF system operators at your site. 3. Retain this document with your system's instructions for Use Manual. For further information or support concerning this issue please contact your local Philips representative in the United States and Canada at 1-800-722-9377, and follow the recorded menu options to reach Customer Solutions Engineer; in all other countries please dial your local Philips Healthcare office.
Quantity in Commerce 197 units
Distribution Worldwide Distribution -- USA (nationwide) including the states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NY, OH, OR, PA, PR, TN, TX, WA and WV. and the countries of: Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Denmark, Egypt, France, Germany, Hungary, India, Israel, Italy, Japan, Netherlands, Pakistan, Philippines, Poland, Russian Fed, Saudi, Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine and United Kingdom.
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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