Events

Alerte De Sécurité sur Model 7700 Mobile C-Arm Fluoroscopic X-Ray Digital Imaging Systems: (1) Compact, (2) Series

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par GE OEC Medical Systems.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    229
  • Date
    2000-12-15
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    The aforementioned x-ray diagnostic systems require replacement of the printed circuit board to enable x-ray initiation. it is possible for the operator to wrap the foot pedal cord around the pedal and press the whip into the foot pedal holder after finishing using the system, the next activation of the system could activate the foot pedal inside its pedestal , by triggering the x-ray, exposing the operator and the patient. the aforementioned x-ray diagnostic systems were defective in accordance with 21 cfr 1003.10 guidelines and did not meet the performance standard of 21 cfr 1020.32 (c). the systems mentioned also did not meet the performance standard of 21 cfr 1020.32 (c) of fluoroscopic performance. "fluoroscopic mode x-ray production should be controlled by equipment requiring continuous operator pressure for the duration of any exposure . " the manufacturer initiated a correction by registered letter sent on july 19, 2000. the fda approved the company's corrective action plan on october 26, 2000.
  • Action
    Make sure you have received the correspondence sent on July 19, 2000, by GE OEC Medical Systems. Identify and collect any affected product from your inventory. For more information, contact your local representative or directly with GE OEC Medical Systems at (801) 328-9330 in the United States.

Device

Model 7700 Mobile C-Arm Fluoroscopic X-Ray Digital Imaging Systems: (1) Compact, (2) Series

Manufacturer

GE OEC Medical Systems
  • Source
    ANVSANVISA