SOMATOM Emotion 16 - Tomography Scanner (2018-02-05)
- Starting date:
- February 5, 2018
- Posting date:
- March 19, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66204
Affected products
SOMATOM Emotion 16 - Tomography Scanner
Reason
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 and could lead to unnecessary radiation exposure.
Affected products
SOMATOM Emotion 16 - Tomography Scanner
Lot or serial number
39285
Model or catalog number
7734713
Companies
- Manufacturer
-
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY