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