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U.S. Department of Health and Human Services

Class 2 Device Recall GEMINI TF PET/CT 64 Slice

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  Class 2 Device Recall GEMINI TF PET/CT 64 Slice see related information
Date Initiated by Firm March 06, 2015
Date Posted June 11, 2015
Recall Status1 Terminated 3 on March 13, 2017
Recall Number Z-1787-2015
Recall Event ID 71134
510(K)Number K052640  
Product Classification System, tomography, computed, emission - Product Code KPS
Product GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Code Information Model #: 882471; Serial #s: 7037, 7205, 7206, 7209, 7212, 7213, 7214, 7217, 7218, 7219, 7221, 7227, 7229, 7231, 7234, 7238, 7241, 7245, 7251, 7252, 7253, 7254, 7255, 7256, 7257, 7258, 7504, 7506, 7509, 7510, 7512, 7515, 7516, 7519, 7524, 7525, 7535, 7537, 7539, 7542, 7543, 7544, 7548, 7549, 7550, 7552, 7553, 7555, 7556, 7557, 7558, 7560, 7561, 7562, 7563, 7567, 7569, 7572, 7574, 7577, 7578, 7579, 7585, 7587, 7589, 7592, 7594, 7595, 7602, 7606 & 7575.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Mr. Yuchol Kim
440-483-2015
Manufacturer Reason
for Recall		 The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 3/9/2015 the firm sent Urgent Field Safety Notices Medical Device Correction letters to their customers.
Quantity in Commerce 71 units
Distribution Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.
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 = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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