Events

Alerte De Sécurité sur X-ray System for Computed Tomography ,; Brand Philips; Risk class III; models:. . Brilliance, Registry: 10216710191; ///. . Ingenuity CT, Record: 10216710209; ///. Serial numbers: 31001/50215/95920/95921/95933/320113.

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 Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc..

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
    1544
  • Date
    2015-03-23
  • 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
    According to the registry holder, there is a serious accident for the patient and operator / technician resulting from the problem: "For the patient: • There is a possibility of disconnection or movement of invasive medical devices. For the Operator / Technician: • There is a possibility of there are compression / crush points in the substructure; and • A possibility of retention between the table and the gantry if the Operator / Technician positions between them to move the patient forward.
  • Cause
    Considering that the maintenance latch is secured and the stem of the maintenance latch is broken, the tabletop can float freely, causing an involuntary horizontal movement.
  • Action
    The company directs the operator to notice a horizontal free floating movement of the table during normal clinical use, immediately stop using the system and contact your Maintenance Engineer. It is important to keep the Safety Warning with the Instructions for Use (IFUs) of the equipment.

Device

X-ray System for Computed Tomography ,; Brand Philips; Risk class III; models:. . Brilliance, Reg...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA