Health product recall

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