Events

Alerte De Sécurité sur CyberKnife Treatment Delivery 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 Accuray.

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
    2018-08-28
  • Date de publication de l'événement
    2018-08-28
  • 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_20180828.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: accuray cyberknife treatment delivery system medical device manufacturer, accuray, has issued a medical device safety alert concerning its cyberknife treatment delivery system. the manufacturer has discovered an issue related to specific batches of calibration film used with the ball-cube ii phantom in calibrating the cyberknife treatment delivery system (cyberknife system). the ball-cube ii phantom calibration film (ball-cube ii film) was not manufactured within necessary dimensions and may introduce up to 0.5mm of positional inaccuracy to the cyberknife system. this inaccuracy is within the 0.95mm specification for overall delivery accuracy of the cyberknife system. however, it is an additional source of error that when added to other sources of error may exceed the expected positional tolerance of the system. according to the manufacturer, only the ball-cube ii film manufactured from 1 august 2017 to 31 july 2018 and labeled with "ashland" are affected. most systems calibrated using the affected bait-cube ii film will still operate within the 0.95mm overall delivery accuracy. a small portion of systems may have up to a 1.45mm error in positional accuracy. the affected users are recommended to take the following actions to ensure cyberknife system positional accuracy is within specifications: stop using and quarantine the affected products. the new ball-cube ii film provided with the customer letter can be used to perform both a 6d skull and fiducial end-to-end test to preliminarily assess the positional inaccuracy. if the results do not meet the acceptance criteria, they should contact the manufacturer to schedule service. product removal and replacement are on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 28 august 2018.

Device

CyberKnife Treatment Delivery System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Accuray CyberKnife Treatment Delivery System
  • Manufacturer
    Accuray

Manufacturer

Accuray