Device Recall GE Advantx Legacy

  • Modèle / numéro de série
    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, 00000502656WK2, 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  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • 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,
  • Description du dispositif
    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.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
  • Source
    USFDA