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: 58524531; 5,877,142; 61676906; 61701347; 61877637; 61965826; 6,213,815; 62218321; 62829796; 6,308,7087; 63090577; 6,374,4537; 63820666; 63842205; 63912144; 63929459; 64046882; 64075140; 62506739.

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
    1508
  • Date
    2015-02-11
  • 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 record holder, there were no reports of injuries due to this failure mode, but when the vertical brake malfunctions, the technician, patient or other users who are near the table may suffer an injury.
  • Cause
    According to the registry holder there is a possible vertical brake failure, which may lead to uncontrolled movement of the patient's bed. there are no reports of users being injured.
  • Action
    The record holder's recommendations, in the event of an uncontrolled vertical movement of the patient's bed, the use of the equipment should be discontinued and the user should contact the local care provider. The company does not guide stopping in the use of the bed. Users who prepare and operate the system with the patient should be aware while the patient is on or near the Patient Bed, especially in the case of intubated patients or in similar situations. These guidelines must be followed until the equipment is corrected.

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