Product Wiki · Recalls · Health Canada — Medical Devices

SOMATOM Definition Systems (2017-11-07) — recall 57992

Health Canada — Medical Devices · Canada · 2017-11-24 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
57992
Date of alert
2017-11-24
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Siemens Healthcare became aware of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/somatom-definition-systems-201

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