Events

Alerte De Sécurité sur Sterrad NX Sterilizer

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

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
    2015-10-02
  • Date de publication de l'événement
    2015-10-02
  • 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_20151002a.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: advanced sterilization products sterrad nx sterilizer medical device manufacturer, advanced sterilization products (asp), has issued a medical device safety alert concerning its sterrad nx sterilizer [part number: 10033]. the manufacturer has recently identified that the sterrad nx sterilization system may exceed the radiated emissions international standard limit by 20 decibel micro-volt per meter (dbμv/m), which equates to 0.001 volt per meter (v/m) at a distance of 10 meters. based on the manufacturer’s analysis, the risk is low for interference to active implantable and wearable devices and other nearby electrical equipment. there is no health consequences anticipated on the issue. the manufacturer advises affected users to continue to take the precautions normally exercised for adjacency of sterrad nx sterilization system with other electromechanical equipment and electronic medical devices. the manufacturer will begin the process of correcting systems to reduce the emissions to meet the international standard limit within the next 90 days. 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 2 october 2015.

Device

Sterrad NX Sterilizer
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Advanced Sterilization Products Sterrad NX Sterilizer
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products