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Urgent safety notice for Siemens SOMATOM users

24 November, 2017
CT scan

Siemens Healthineers has issued an Urgent Field Safety notice CT053/17/S for users of the following CT scanners:

·      SIEMENS SOMATOM Definition AS

·      SIEMENS SOMATOM Definition DS

·      SIEMENS SOMATOM Definition Edge

·      SIEMENS SOMATOM Definition Flash

·      SIEMENS SOMATOM Force

The notice reads: “Siemens Healthcare became aware of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. topograms.

“Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate. Potentially, the CARE Dose4D software will select the maximum tube current for the uppermost part of the skull, thus leading to unnecessary radiation exposure.

It adds: “Our experts will develop a solution to correct the problem with top priority. As soon as we release the correction, we will inform you concerning the start of the measure and when this correction has been successfully implemented.

“We appreciate your understanding and cooperation with this safety advisory notice and ask you to immediately instruct your personnel accordingly.

“Please ensure that this safety advisory notice is placed in the medical device’s Instructions for Use.

“Your personnel should maintain awareness until a solution has been implemented.”

If you use one of these systems and have not yet received a notification from Siemens, please contact them for preventative/corrective advice.

Read the full notice here.

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