Events

Alerte De Sécurité sur Practix Convenio Mobile X-ray System

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 Medical Systems.

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
    2012-05-31
  • Date de publication de l'événement
    2012-05-31
  • 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_20120531.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 practix convenio mobile x-ray system medical device manufacturer, philips medical systems issued a safety alert concerning practix convenio mobile x-ray system with serial number pc1-0504 through pc1-0588. philips warned that when the affected systems are switched off or when the tube arm is parked into its designated parking position (x-ray generator switch off), a radiation pulse (50 kv, 2.5 μgy) is inadvertently generated. this occurs on a small number of systems with a particular electronic component on the controller board. according to philips, there is a potential that the radiation from this extra x-ray pulse might reach a person in the vicinity of the system, resulting in unintended exposure. this extra radiation may also cause artifacts on x-ray images, if a cassette was in the path of the radiation. philips supplemented that the controller board of the affected systems will be updated later. meanwhile, the affected users are advised to completely close the shutters of the collimator before switching off the system and before bringing the tube assembly to its parking position. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted 31 may 2012.

Device

Practix Convenio Mobile X-ray System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips Practix Convenio Mobile X-ray System
  • Manufacturer
    Philips Medical Systems

Manufacturer

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