| Class 2 Device Recall PET Discovery LS | |
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
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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
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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 |
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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
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