Events

Alerte De Sécurité sur On-Board Imager

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

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
    2014-03-26
  • Date de publication de l'événement
    2014-03-26
  • 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_20140326.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: varian medical systems on-board imager medical device manufacturer, varian medical systems, has issued a medical device safety alert concerning its on-board imager. the manufacturer has received three reports that the shaft of the type 01 elbow motor for exact arms used in the on-board imager [obi] device have failed due to belt over-tensioning. this over-tensioning would have taken place during servicing. this failure would allow the exact arm to swing freely with gravity. no injuries have been reported to-date. only type 01 elbow motors are subject to these potential failures. according to the manufacturer, potential injury from the kv source striking a patient is dependent upon the anatomic site being treated and the height of the couch. the risk is greatest when the obi x-ray source is extended or retracted while it is above the patient. a geometric analysis determined that when the couch is positioned for a pelvis treatment [e.G., prostate treatments], the head of the patient could be positioned within the arc travelled by the kv source. if the kv source were to strike the patient’s head or chin, a fracture injury is possible. pelvic treatments with couch vertical positions less than 10 centimeters below isocenter have the highest potential for injury. the manufacturer instructs all affected users not to extend or retract the kv source arm when it is above a patient until the manufacturer inspects the obi exact arms. users should ensure that the gantry is positioned so that the kv source is lateral to, or underneath, the patient-couch prior to extending or retracting the arm. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 26 march 2014.

Device

On-Board Imager
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Varian Medical Systems On-Board Imager
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems