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U.S. Department of Health and Human Services

Class 2 Device Recall GE Advantx Legacy

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 Class 2 Recall
GE Advantx Legacy
see related information
Date Posted September 19, 2008
Recall Status1 Open
Recall Number Z-1611-2008
Recall Event ID 49467
Premarket Notification
510(K) Numbers
K011624  K973039 
Product Classification Table, Radiographic, Tilting - Product Code IXR
Product Advantx Legacy Radiographic and Fluoroscopic systems, model 2102424, 2118104, 2157009, 2183000, 2206038, 2206048, 2206056, 2224559, 2258627, 2268730, 2330340, 2333974, 2118104-2, 2118104-3, 2118104-4, 2118104-5, 2118104-6, 2118104-7, 2118104-8, 2139574-2, 2147592-13, 2171204-2, 46-262751G6, 46-262751G7, 46-262751G8, 46-275382G58, and 46-302056G1. GE Medical Systems - Americas: Milwaukee, USA. The device is used to perform fluoroscopic examination of human anatomy.
Code Information serial numbers: 000000000BH563, 00000004777GP9, 00000005003GP9, 00000014648GP0, 00000046998VP1, 00000048828VP8, 00000054168VP0, 00000054198VP7, 00000062777ES8, 00000062779ES4, 00000062797ES6, 00000062797VP6, 00000062813VP1, 00000062839ES6, 00000065436VP8, 00000066102DP5, 00000066138DP9, 00000076156MA9, 00000077242DP6, 00000077245DP9, 00000077246DP7, 00000077348MA1, 00000080468MA2, 00000084227VP8, 00000095705VP0, 00000097498WK1, 000000T7113MA8, 00000419764BU6, 00000431324BU3, 00000491331WK5, 00000493021WK0, 00000493022WK8, 00000494787WK5, 00000495471WK5, 00000495922WK7, 00000495960WK7, 00000498299WK7, 00000498516WK4, 00000498844WK0, 00000499720WK1, 00000499789WK6, 00000499936WK3, 00000500252WK2, 00000500371WK0, 00000500420WK5, 00000500452WK8, 00000500631WK7, 00000500800WK8, 00000500961WK8, 00000501080WK6, 00000501165WK5, 00000501317WK2, 00000501405WK5, 00000501497WK2, 00000501624WK1, 00000501678WK7, 00000501690WK2, 00000501845WK2, 00000502382WK5, 00000502469WK0, 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Recalling Firm/
Manufacturer
GE Healthcare
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
GE Healthcare was notified that 2 recently installed Precision 500D systems were not in compliance with portions of the Performance Standard for Diagnostic X-ray Equipment. X-ray production was possible from the fluoroscopic X-ray tube when the Primary Protective Barrier was not in position to intercept the X-ray beam. Users are recommended to follow good clinical standards to ensure the Image I
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action A Product Safety Notification letter, dated 01/09/2008 was sent to affected customers. This letter described the safety issue, affected product and safety instructions. A GE Field Engineer will schedule a field visit to affected customers to inspect and replace the park latch switch as needed.
Quantity in Commerce 2863 total (2744 US / 119 OUS)
Distribution Nationwide, Washington D.C. and Puerto Rico and OUS to include: ARGENTINA, AUSTRALIA, BRAZIL, CANADA, CHILE, DOMINICAN REPUBLIC, EGYPT, GERMANY, HONDURAS, INDIA, INDONESIA, IRELAND, JAMAICA, KOREA, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, PANAMA, RUSSIAN FEDERATION, SAUDIA ARABIA, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM,
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IXR and Original Applicant = GE MEDICAL SYSTEMS
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