Events

Alerte De Sécurité sur Infinia and Infinia Hawkeye, Millennium VG, VG Hawkeye and VariCam Nuclear Medicine systems

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par GE 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
    2014-02-11
  • Date de publication de l'événement
    2014-02-11
  • 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_20140211a.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: ge healthcare infinia and infinia hawkeye, millennium vg, vg hawkeye and varicam nuclear medicine systems medical device manufacturer, ge healthcare, has issued a field safety notice concerning all configurations of infinia and infinia hawkeye, millennium vg, vg hawkeye and varicam nuclear medicine systems. the manufacturer has recently become aware of a potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. this failure mode has been observed on a single system for a whole body scan, in which the detector moved to the home position and then slowly started drifting inward toward the patient. this generated both a visual and audio alert condition on both the console and the gantry. a potential life-threatening hazardous situation may occur if there is unintended radial detector motion leading to patient contact. the manufacturer advises users to monitor the patient and the system during the entire scan procedure to ensure that there is enough clearance between the patient and the detectors, and to follow the technical advice listed in the field safety notice. a representative from the manufacturer will perform a software upgrade on each affected system. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 february 2014.

Device

Infinia and Infinia Hawkeye, Millennium VG, VG Hawkeye and VariCam Nuclear Medicine systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: GE Healthcare Infinia and Infinia Hawkeye, Millennium VG, VG Hawkeye and VariCam Nuclear Medicine systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare