Events

Alerte De Sécurité sur Commercial Name: Allura Xper Angiography Equipment; ANVISA registration numbers: 10216710153; Risk class: III; Aura affected: Allura Xper FD20; Serial numbers affected: 2352 (which is in Ribeirão Preto-SP).

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
    1859
  • Date
    2016-04-01
  • 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
    Philips will contact you for scheduling and Philips maintenance engineers will install Software that solves the audible alarm problem. If you need any additional information or support regarding this issue, please contact our Solution Center at 0800-701-7789. Reception from Mon to Sat from 07 to 19h.
  • 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. 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.
  • Action
    Field Action Code: FCO72200309. Field Correction through Software Installation that solves the sound alarm problem (Software update R8.1.15 to R8.1.17.2) //////////// Recommendations to users and patients: Non-issue of 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.

Device

Commercial Name: Allura Xper Angiography Equipment; ANVISA registration numbers: 10216710153; Ris...

Manufacturer

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