Events

Alerte De Sécurité sur allura xper systems - allura xper fd10 , allura xper fd10/10 , allura xper fd20, allura xper fd20/10, allura xper fd20/20 and allura cv20

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Philips Healthcare.

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
  • Date
    2011-08-04
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110804a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Field safety notice: philips allura xper systems - allura xper fd10 (f/c), allura xper fd10/10 (incl. or table), allura xper fd20, allura xper fd20/10, allura xper fd20/20 and allura cv20 philips healthcare has issued a field safety notice to the customers of allura xper systems. investigation of field problems on the allura xper systems showed that there is a problem related to the harddisk firmware. the hard disk drive itself is working fine but the used firmware suffers from an incorrect incrementing smart counter. this might result in a very high “raw read error” count which will lead in a so called “smart trip” and subsequently will take the hard disk drive offline. consequently the system might intermittently freeze. this can vary from several seconds up to one minute. if during a procedure the system intermittently freezes for several seconds and up to one minute, the system does not generate x-ray anymore and no geometry movement is possible during this period of time. if this happens during a critical phase in a procedure this might lead to a disturbance in the procedure and a possible injury to the patient. this intermittent image freeze / system freeze is not foreseeable or recognizable by the user. the manufacturer recommended customers not to reboot or take any other actions until the system proceeds on its own, because this could slowdown the systems automatically recovery. the manufacturer will provide users a cd with the correct firmware and an installation procedure to implement the corrective actions. according to the local supplier, hong kong is affected. the local supplier is following up the issue with its customers. if you are in possession of the affected product, please contact your supplier (hotline: 2821-5473) for necessary actions.

Device

allura xper systems - allura xper fd10 , allura xper fd10/10 , allura xper fd20, allura xper fd20...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: [4 Aug 2011] Philips Allura Xper Systems - Allura Xper FD10 (F/C), Allura Xper FD10/10 (incl. OR table), Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/20 and Allura CV20
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DH