Events

Safety Alert for Somatom Definition FORCE with VA50A, VA50A_SP2

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Siemens..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-04-06
  • Event Date Posted
    2016-04-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160406a.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    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
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: SOMATOM Definition FORCE with VA50A, VA50A_SP2
  • Manufacturer
    Siemens.

Manufacturer

Siemens.