Events

Alerte De Sécurité sur STERRAD 100S and STERRAD 200 systems

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
    2013-04-09
  • Date de publication de l'événement
    2013-04-09
  • 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_20130409d.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 100s and sterrad 200 systems medical device manufacturer, advanced sterilization products (asp) (a johnson & johnson company) has issued a field safety notice concerning sterrad booster with the olympus cyf-v2 and cyf-v2r when processing in the sterrad 100s and sterrad 200 systems. previously, the use of a sterrad booster for these models was not required. upon joint review of the construction of these endoscopes, asp and olympus corporation decided a sterrad booster is required because the “effective” length of the channels slightly exceeds the 500mm threshold. the construction of these endoscopes has not changed. endoscopes with lumen specifications that exceed a length of 500mm require a sterrad booster for sterrad 100s and sterrad 200 systems when used outside of the us. asp has determined that the risk to a patient due to processing the olympus endoscope models cyf-v2 and cyf-v2r without a booster is extremely low. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 9 april 2013.

Device

STERRAD 100S and STERRAD 200 systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Advanced Sterilization Products STERRAD 100S and STERRAD 200 systems
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products