Events

Alerte De Sécurité sur Allura Xper Angiography Equipment Angiography Equipment Angiography Equipment ANVISA Registration Number: 10216710153 Hazard Class: III Model Affected: Allura Xper FD10 Ceiling / Allura Xper FD10 Ceiling / Allura Xper FD20 Ceiling / Allura Xper FD20 Floor / Allura Xper FD10 OR Table / Allura Xper FD20 OR Table Serial numbers affected: 1330; 1308.

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
    2279
  • Date
    2017-04-25
  • 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
    Failure to emit the audible alarm occurs very intermittently. The user should always observe the real-time dose information and cumulative fluoroscopy time provided by the system. The fault condition is reset when the case of a new patient is started or when the system is reset. #### Update of the field action: UPDATED ON 12/11/2017, the company presented the completion report of the field action, with sending of necessary evidences and corrective actions.
  • Cause
    Philips healthcare has identified, through customer complaints and internal testing, an intermittent electronic defect in the product. under certain circumstances, a software error may lead to a situation where the five-minute fluoroscopy beep is not emitted as required in 21cfr1020.32 (h) (2) (ii) and iec 60601-2-54 , clause 203.6.2.1.C. no injuries attributed to the problem were reported.
  • Action
    Field Action Code FCO72200350 triggered under the responsibility of the company Philips Medical Systems Ltda. Company will make correction in the field.

Device

Allura Xper Angiography Equipment Angiography Equipment Angiography Equipment ANVISA Registration...

Manufacturer

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