Events

Alerte De Sécurité sur multidiagnost eleva fd

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
    2015-01-21
  • Date de publication de l'événement
    2015-01-21
  • 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_20150121a.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
    Medical device safety alert: philips healthcare multidiagnost eleva fd medical device manufacturer, philips healthcare, has issued a field safety notice concerning multidiagnost eleva fd [product code: 708037]. in the md eleva system, software license keys are used to enable particular functionality. the manufacturer has discovered that in software release r6.1.1sp2 and r6.1.2 intermittently part of the software keys are not loaded: the license key for spectral filter the license key for full table tilt range if the license key for spectral filter is not loaded, then a higher than expected patient dose will occur in low dose mode for positioning of the patient, positioning of the x-ray beam, and/or in situations in which the x-ray image has lots of contrast. if the license key for full table tilt range is not loaded, then the table tilt range will be restricted. in such a case not all desired image projections are possible. the manufacturer will perform software upgrade for affected units before may 2015. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 january 2015.

Device

multidiagnost eleva fd
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips Healthcare MultiDiagnost Eleva FD
  • Manufacturer
    Philips Healthcare

Manufacturer

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