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Class 2 Device Recall PET Discovery ST 16 |
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Date Initiated by Firm |
July 17, 2015 |
Date Posted |
September 21, 2015 |
Recall Status1 |
Terminated 3 on March 08, 2016 |
Recall Number |
Z-2803-2015 |
Recall Event ID |
71842 |
510(K)Number |
K041543
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Product Classification |
System, tomography, computed, emission - Product Code KPS
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Product |
PET Discovery ST 16
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Code Information |
00000407058CN7 B5127901 00000393804CN0 YE0524 00000007118PT3 A098PE01 00000005880PT0 853450026 00000295121CN8 469525DLS 00000331760CN9 256327PET 00000305946CN6 201599DST 00000314955CN6 RADNETPT1813 00000362166CN1 203694DST16 00000354677CN7 918744PETCT 00000359856CN2 713704DST 00000364001CN8 845454PCT 00000299430CN9 817927DST 00000011079PT1 662232DST 00000005835PT4 256705PS2 00000010481PT0 615320DST 00000005903PT0 856794DISCST 00000412917CN7 818DCCDST |
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
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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.
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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 |
18 |
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 and Original Applicant = GE HEALTHCARE
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