Events

Alerte De Sécurité sur Infinia nuclear medicine systems; VG and VG Hawkeye nuclear medicine systems; Helix nuclear medicine systems; Brivo NM615; Discovery NM630; Optima NM/CT640; and Discovery NM/CT 670

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
    2013-07-05
  • Date de publication de l'événement
    2013-07-05
  • 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_20130705c.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 nuclear medicine systems it has come to our attention that medical device manufacturer, ge healthcare has initiated a field safety corrective action concerning its nuclear medicine systems. the affected products are 1) infinia nuclear medicine systems; 2) vg and vg hawkeye nuclear medicine systems; 3) helix nuclear medicine systems; 4) brivo nm615; 5) discovery nm630; 6) optima nm/ct640; and 7) discovery nm/ct 670. on 5 june 2013, ge healthcare became aware of an incident in the united states that a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 due to a portion of the system falling onto the patient during the scan. investigation by the manufacturer found that bolts securing the camera to the gantry were loose, thereby stressing the support mechanism and resulting in the incident. because of the similarities in the design of support mechanisms across many products, the manufacturer has included all types and manufacturing dates of infinia and infinia hawkeye nuclear medicine systems; all types and manufacturing dates of vg and vg hawkeye nuclear medicine systems; and all types and manufacturing dates of helix nuclear medicine systems by elscint ltd. the manufacturer stated that the issue should also affected brivo nm615, discovery nm630, optima nm/ct640, discovery nm/ct670 due to similarities in basic mechanical concepts between these devices and the infinia systems. ge healthcare will inspect all affected systems to verify that the support mechanism fasteners are secured properly. furthermore, ge healthcare recommends that users to cease use of their nuclear medicine system until ge healthcare can complete an inspection of their system. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 05 july 2013.

Device

Infinia nuclear medicine systems; VG and VG Hawkeye nuclear medicine systems; Helix nuclear medic...
  • Modèle / numéro de série
  • Classification du dispositif
    Radiology Devices
  • Description du dispositif
    Medical Device Safety Alert: GE Healthcare nuclear medicine systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare