Events

Alerte De Sécurité sur OPTIMA CARDIOVASCULAR IMAGIOLOGY SYSTEM, models CL323 and IGS320, risk class III, registration 80071260314. Serial number: see attached chart.

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 Healthcare do Brasil; GE HUALUN MEDICAL SYSTEMS CO., LTD..

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
    1759
  • Date
    2015-11-23
  • 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
    The problem may occur before or during an interventional fluoroscopy procedure. The total and unrecoverable loss of the monitor's display is a risky situation that prevents the use of the equipment for any need and therefore will require another equipment or that the patient is transferred. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client and replacement parts.
  • Cause
    Security issue related to video loss of monitors during interventional procedures. a video switch power failure can result in loss of real-time video and reference monitors located in the procedural and control room areas. no radiology images will be displayed during a real-time acquisition or during review when the power supply fails.
  • Action
    According to company information, the user can continue to use the system. Prior to each use, established procedures should be in place to treat patient in case of loss of fluoroscopy imaging during an examination. The user must ensure that the equipment operates before use. If the failure occurs during the interventional examination, it is advised to interrupt the acquisition of the image immediately and finish the examination to avoid unnecessary exposure. The company will contact you to replace the power supply of the video switch. Action code: FMI12237.

Device

OPTIMA CARDIOVASCULAR IMAGIOLOGY SYSTEM, models CL323 and IGS320, risk class III, registration 80...

Manufacturer

GE Healthcare do Brasil; GE HUALUN MEDICAL SYSTEMS CO., LTD.