Rappel de Device Recall GE Precision 500D

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par GE Healthcare.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    49467
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1610-2008
  • Date de mise en oeuvre de l'événement
    2008-01-02
  • Date de publication de l'événement
    2008-09-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2011-12-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Fluoroscopic X-Ray System - Product Code JAA
  • Cause
    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.
  • 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.

Device

  • Modèle / numéro de série
    serial numbers: 00000004108GQ7, 00000004874GQ4, 00000006742GQ1, 00000007111GQ8, 00000008717GQ1, 00000008892GP2, 00000010136GQ0, 00000012808GP2, 00000013547GP5, 00000013737GP2, 00000013844GP6, 00000985953WK9, 00000987224WK3, 00000987333WK2, 00000989376WK9, 00012966GP8000, 00000000BRBGDM, 00000000BRBGDR, 00000000BRBUF8, 00000000BRD138, 00000000BRF490, 00000000BRF49B, 00000000BRBBXV, 00000000BRBL7V, 00000000BRETRE, 00000986515WK5, 00000097958WK2, 000000980212WK, 00000098186WK0, 00000098235WK4, 00000098734WK5, 00000970756WK3, 00000971704WK2, 00000972504WK5, 00000972505WK2, 00000972772WK8, 00000973070WK6, 00000973500WK2, 00000973502WK8, 00000973616WK6, 00000973617WK4, 00000973618WK2, 00000973624WK0, 00000973883WK2, 00000973884WK0, 00000973885WK7, 00000974085WK3, 00000974087WK9, 00000974410WK3, 00000974411WK1, 00000974412WK9, 00000974445WK9, 00000974446WK7, 00000974447WK5, 00000974676WK9, 00000974677WK7, 00000974678WK5, 00000975166WK0, 00000975167WK8, 00000975169WK4, 00000975171WK0, 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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
    GE Precision 500D, model 2288798, 2289299, 2290479, 2305472, 2305473, 2305495, 2336900, 2345243, 2401181, 2403790, 2403791, 2404103, 2407276, 2407576, 5179385, 2289299-2, 2290479-2, 2345260-12, 2345260-3, 2403790-3, and 2403791-3, GE Medical Systems - Americas: Milwaukee, USA. The device is used to perform fluoroscopic examination of human anatomy.
  • Manufacturer

Manufacturer

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