Events

Alerte De Sécurité sur OEC 9900 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
    2014-07-21
  • Date de publication de l'événement
    2014-07-21
  • 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_20140721a.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 oec 9900 systems medical device manufacturer, ge healthcare, has issued a field safety notice (fsn) concerning oec 9900 systems manufactured between 9 oct 2013 and 9 jun 2014, and oec 9900 systems that had an extension arm replaced between 9 oct 2013 and 9 jun 2014. the manufacturer issued an urgent medical device correction notice in earlier 2014 regarding a monitor arm screw issue. the screws that attach the workstation monitor spring arm to the extension arm may fail, causing the spring arm and monitor to tilt or fall forward. based on further investigation, the manufacturer is taking additional actions to correct the screws that attached the workstation monitor spring arm. the manufacturer advises users of the followings: use caution when positioning or extending the workstation articulating arm. refrain from positioning staff or patients directly underneath or in front of a workstation monitor. the manufacturer’s local field engineer will contact users to coordinate the replacement of the screws, and ensure that the system meets specifications. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 21 july 2014.

Device

OEC 9900 systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: GE Healthcare OEC 9900 systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare