Events

Alerte De Sécurité sur Infinia, VG, VG Hawkeye and Helix nuclear medical 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
    2013-06-24
  • Date de publication de l'événement
    2013-06-24
  • 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_20130624a.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, vg, vg hawkeye and helix nuclear medical systems the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning infinia, vg, vg hawkeye and helix nuclear medicine systems which are manufactured by ge healthcare. the affected products are manufactured from 2003-2013 for all infinia nuclear medicine systems; 1996-2003 for vg and vg hawkeye nuclear medicine systems and1992-1996 (by elscint ltd) for helix nuclear medicine systems. ge healthcare has recently became aware of an incident in the united states, a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 where the equipment fell onto the patient during the scan. at this time, the manufacturer has not been permitted access to the equipment. as a result, the manufacturer has not been able to determine the root cause of this incident. the manufacturer recommends that qualified service personnel to maintain the equipment and that preventative maintenance procedures are executed according to the schedule provided in customer documentation. customers are asked to re-review safety chapter sections with appropriate personnel to ensure proper operation of the equipment. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00629-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 june 2013.

Device

Infinia, VG, VG Hawkeye and Helix nuclear medical systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: GE Healthcare Infinia, VG, VG Hawkeye and Helix nuclear medical systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare