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U.S. Department of Health and Human Services

Class 2 Device Recall GEMINI GXL 16 Slice CT/PET System

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  Class 2 Device Recall GEMINI GXL 16 Slice CT/PET System see related information
Date Initiated by Firm July 01, 2015
Date Posted July 22, 2015
Recall Status1 Terminated 3 on June 26, 2018
Recall Number Z-2193-2015
Recall Event ID 71699
510(K)Number K051170  
Product Classification System, tomography, computed, emission - Product Code KPS
Product GEMINI GXL 16 Slice CT/PET System.

The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Code Information Model #882410 GEMINI GXL 16 Slice (453567971891); Serial Number: 4170 & 4147A.
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		 Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
FDA Determined
Cause 2		 Software design
Action On 7/6/2015 the firm sent Field Safety Notices to their customers.
Quantity in Commerce 2 units
Distribution Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.
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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