Events

Alerte De Sécurité sur Navios flow cytometer

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
    2013-01-22
  • Date de publication de l'événement
    2013-01-22
  • 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_20130122.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 navios flow cytometer the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning navios flow cytometer, manufactured by beckman coulter. the affected devices are a52101 navios 6 colours / 2 lasers; a52102 navios 8 colours / 2 lasers; and a52103 navios 10 colours / 3 lasers. the manufacturer has identified an internal wiring problem in certain navios reagent carts that may result in a severe shock hazard and instrument failure or shut down. during manufacture the compressor cable assembly may have been installed in a configuration that would allow the wiring to come into contact with the compressor frame during operation. normal vibration of the compressor frame could wear through the wiring’s shielding and insulation material and connect electrical current to the reagent cart housing, resulting in the potential exposure of a user or service engineer to a severe shock hazard. no shocks to users or service personnel have been reported to date. the manufacturer advises users that if the compressor fails or the system shuts down unexpectedly, they should unplug from the laboratory power source and call beckman coulter customer service. the manufacturer will inspect affected devices and make corrections if an issue exists with the wiring within compressor module. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con224428 if you are in possession of the product, please contact your supplier for necessary actions. posted on 22 january 2013.

Device

Navios flow cytometer
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Beckman Coulter Navios flow cytometer
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter