Events

Alerte De Sécurité sur UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System

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

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
    2016-08-11
  • Date de publication de l'événement
    2016-08-11
  • 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_201608011.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: beckman coulter unicel dxh slidemaker stainer coulter cellular analysis system medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its unicel dxh slidemaker stainer coulter cellular analysis system [part number reference 775222; all software revisions]. the manufacturer has received and confirmed a report of a fire within the stainer module of a customer’s dxh slidemaker stainer. the fire was fully contained within the stainer module. the event was preceded by a significant increase in the frequency of the automatic top-off of the module’s methanol bath. users are being advised to discontinue use of the stainer module to reduce the potential for flammable liquids coming into contact with electrical components in the stainer module possibly causing a fire. the manufacturer is investigating the reported incident to determine the root cause, and define and implement required corrective and preventive actions. the manufacturer is advising users to: immediately discontinue use of the stainer module; drain all liquids from the stainer module; follow the directions provided for placing the stainer module in extended shutdown and disabling the stainer.; and a manufacturer’s service representative will schedule a visit to modify the stainer module so that it remains disabled and cannot be used until further corrective action is implemented. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 august 2016.

Device

UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Beckman Coulter UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter