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Class 2 Device Recall GEMINI TF 16 Slice CT/PET System |
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Date Initiated by Firm |
July 01, 2015 |
Date Posted |
July 22, 2015 |
Recall Status1 |
Terminated 3 on June 26, 2018 |
Recall Number |
Z-2195-2015 |
Recall Event ID |
71699 |
510(K)Number |
K052640
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Product Classification |
System, tomography, computed, emission - Product Code KPS
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Product |
GEMINI TF 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 #882470 GEMINI TF 16 Slice (453567983931); Serial Number: 7052, 7060, 7093, 7096, 7121, 7123, 7128, 7129, 7185, 7187, 7220, 7226 & 7570. |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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For Additional Information Contact |
Mr. Yuchol Kim 440-483-2015
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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.
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FDA Determined Cause 2 |
Software design |
Action |
On 7/6/2015 the firm sent Field Safety Notices to their customers. |
Quantity in Commerce |
13 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
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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.
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510(K) Database |
510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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