Events

Alerte De Sécurité sur Navigation System II-Cart and Articulated Arm Camera

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Stryker Instruments and Stryker Leibinger GmbH & Co. KG.

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
    2015-05-19
  • Date de publication de l'événement
    2015-05-19
  • 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_20150519.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: stryker navigation system ii-cart and articulated arm camera medical device manufacturer, stryker instruments and stryker leibinger gmbh & co. kg, has issued a field safety notice concerning navigation system ii-cart and articulated arm camera, with the following details: navigation system ii-cart: product code 7700-100-000 distributed from 23 dec 2011 to 3 aug 2012 articulated arm camera: product code 7700-103-001 distributed from 23 dec 2011 to 3 aug 2012 articulated arm camera (refurbished): product code 7700-103-001u distributed from 23 dec 2011 to 3 aug 2012 according to the manufacturer, there is a potential that the weld seam between the main stud and the two flaps on the articulated arm was not welded in the correct location, which may result in failure of the arm joint. a failure in the weld joint could result in interruption or discontinued use of the navigation system. the manufacturer will perform inspection to all affected systems. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 may 2015.

Device

Navigation System II-Cart and Articulated Arm Camera

Manufacturer

Stryker Instruments and Stryker Leibinger GmbH & Co. KG
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DH