Events

Alerte De Sécurité sur Somatom Definition FORCE with VA50A, VA50A_SP2

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

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
    2016-04-06
  • Date de publication de l'événement
    2016-04-06
  • 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_20160406a.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: somatom definition force with va50a, va50a_sp2 the medicines and healthcare products regulatory agency (mhra) of united kingdom posted a medical device safety alert concerning somatom definition force with va50a, va50a_sp2, manufactured by siemens. [material number: 10742326]. the manufacturer recently detected that the use of the neonate head with pediatric kernel hp38, a special image reconstruction programme for ct images, could result in artefacts and furthermore in misdiagnosis, as any or delayed medical treatment within the skull is a surgical and time critical event. according to the manufacturer, this arithmetic error within neonate head with pediatric kernel hp38 is not affecting any other kernels and reconstruction modes. as the reconstruction of images uses the raw data in any case, no additional dose or scan with additional dose has to be applied to the patient. in any case of uncertainty, users are advised to use additional and alternative diagnostic systems before they start the medical treatment. the manufacturer is advising users not to use neonate head with pediatric kernel hp38 anymore until they are informed about the corrective actions to improve this behaviour. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-28-march-to-01-april if you are in possession of the affected products, please contact your supplier for necessary actions posted on 6 april 2016.

Device

Somatom Definition FORCE with VA50A, VA50A_SP2
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: SOMATOM Definition FORCE with VA50A, VA50A_SP2
  • Manufacturer
    Siemens.

Manufacturer

Siemens.