Events

Alerte De Sécurité sur Gemstar docking station (model number: 13075)

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

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
    2011-09-22
  • 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_20110922.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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Field safety alert: gemstar docking station (model number: 13075) it comes to our attention that hospira limited hk alerted the healthcare professionals and customers that complaints related to fluid ingress into the gemstar docking station (model number: 13075) have been received from december 2008 to july 2011. hospira requests healthcare professionals and customers to follow the guidelines below for continued use of their docking station while hospira is in process of developing design improvements to mitigate this risk: do not hang or place fluid containers over the docking station where they could leak fluid on the device; do not spray fluid, such as cleaning solution, directly on the docking station; and clean the docking station using a cloth dampened with an approved cleaning solution according to the local supplier, the product has been distributed to local hospitals and the local supplier has informed the hospitals for observing these guidelines. so far no complaint is received related to this alert. hospira is in the process of developing design improvements to mitigate this risk. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Gemstar docking station (model number: 13075)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Gemstar docking station (model number
  • Manufacturer
    Hospira Limited HK

Manufacturer

Hospira Limited HK
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    DH