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U.S. Department of Health and Human Services

Class 2 Device Recall PET Discovery LS

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  Class 2 Device Recall PET Discovery LS see related information
Date Initiated by Firm July 17, 2015
Date Posted September 21, 2015
Recall Status1 Terminated 3 on March 08, 2016
Recall Number Z-2802-2015
Recall Event ID 71842
510(K)Number K040172  
Product Classification System, tomography, computed, emission - Product Code KPS
Product PET Discovery LS
Code Information 00000336259CN7 82445150008 00000357522CN2 RADNETPT608 00000316259CN1 210351MSDLS 00000293036CN0 352597PET 00000843236YM1 607766DLSPET 00000003458PT7 337407DLS 
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
FDA Determined
Cause 2		 Process control
Action GE Healthcare sent an "Urgent Medical Device Correction" letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. Ref# 25463
Quantity in Commerce 6
Distribution Worldwide Distribution - US (nationwide) and to the countries of : ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGRY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, MEXICO, NORWAY, POLAND, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN and UNITED KINGDOM.
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 = GE MEDICAL SYSTEMS
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