Events

Alerte De Sécurité sur EQUIPMENT FOR ANGIOGRAPHY ALLURA XPER, FD10 (ground); FD10 (ceiling); FD20 (ground); FD20 (ceiling); FD10OR Table; FD20 OTable; FD10 / 10; FD20 / 20 OR Table; FD20 / 10 OR Table; registry 10216710153 and 10216710206, hazard class III, series affected: 405/377.

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 Nederland B.V..

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
    1715
  • Date
    2015-05-15
  • 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
    According to the record holder's information, intermittent failure of fluoroscopy may result in a temporary discontinuation of procedures and delay in treatment. #### UPDATED ON 7/18/2017, the company issued a completed field action report confirming the performance of correction, as provided.
  • Cause
    Software failure that can lead to intermittent and short-term unavailability of the fluoroscopy function.
  • Action
    The company will update the software, installation of version R8.2.16.1, to correct the problem. The company clarifies that upon initiating fluoroscopy, the user may receive a "Fluoro failed, please retry" message and Fluoroscopy will be unavailable. Fluoroscopy repeat solves this situation in most cases. The user may need to repeat more than once in approx. 2% of events. The failure mode has no impact on the performance of active fluoroscopy. Once started, performing an active fluoroscopy continues until the pedal is released.

Device

EQUIPMENT FOR ANGIOGRAPHY ALLURA XPER, FD10 (ground); FD10 (ceiling); FD20 (ground); FD20 (ceilin...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA