Somatom Emotion 16-Slice Configuration and Somatom Perspective - CT Scanner (2018-02-05)
- Starting date:
- February 5, 2018
- Posting date:
- March 13, 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-66124
Affected products
- SOMATOM EMOTION 16-SLICE CONFIGURATION
- SOMATOM PERSPECTIVE - CT 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
A. SOMATOM EMOTION 16-SLICE CONFIGURATION
Lot or serial number
85828
Model or catalog number
10165877
Companies
- Manufacturer
-
Siemens Shanghai Medical Equipment Ltd.
278 Zhouzhu Road
Shanghai
201318
CHINA
B. SOMATOM PERSPECTIVE - CT SCANNER
Lot or serial number
121001
87596
Model or catalog number
10495568
Companies
- Manufacturer
-
Siemens Shanghai Medical Equipment Ltd.
278 Zhouzhu Road
Shanghai
201318
CHINA