Events

Alerte De Sécurité sur TEXAS Bronchoscope Tube

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Richard Wolf GmbH.

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
    2018-09-21
  • Date de publication de l'événement
    2018-09-21
  • 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_20180921a.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: richard wolf gmbh texas bronchoscope tube medical device manufacturer, richard wolf gmbh, has issued a medical device safety alert concerning its texas bronchoscope tube [product numbers: 825200641, 825200841, 825200842, 825201041, 825201241, 825201441, 825210830, 825211230, and 825211430]. the manufacturer became aware of a potential deficiency of its texas bronchoscope tube product. non-functionally relevant bonding points / cemented areas of the affected products may come loose and therefore lead to an extension of the operating time. generally the affected user discovers such separations of fibers of glue during the visible and the function inspection. they are advised to check their stock and return the affected products to the manufacturer for device correction. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 21 september 2018.

Device

TEXAS Bronchoscope Tube
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medical Device Safety Alert: Richard Wolf GmbH TEXAS Bronchoscope Tube
  • Manufacturer
    Richard Wolf GmbH

Manufacturer

Richard Wolf GmbH