SOMATOM Definition Systems (2017-11-07)

Starting date:

November 7, 2017

Posting date:

November 24, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Hospitals, General Public, Healthcare Professionals

Identification number:

RA-65166

• Reason
• Affected products

Affected products

A. SOMATOM DEFINITION-MAIN UNIT
B. SOMATOM DEFINITION AS -MAIN UNIT
C. SOMATOM DEFINITION FLASH SYS -MAIN
D. SOMATOM DEFINITION EDGE SYSTEM -CT SYSTEM
E. SOMATOM FORCE

Reason

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.

Affected products