SOMATOM Sensation Open, Sensation 4, Emotion Duo, Sensation 16 System - Main Unit, and Sensation/Cardiac 64 (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-66202
Affected products
A. SOMATOM Sensation Open - (P30L, KIT)
B. SOMATOM Sensation 4
C. SOMATOM Emotion Duo
D. SOMATOM Sensation 16 System - Main Unit
E. SOMATOM Sensation/Cardiac 64
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 Sensation Open - (P30L, KIT)
Lot or serial number
49225
49593
49682
Model or catalog number
88 72 017
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
B. SOMATOM Sensation 4
Lot or serial number
57114
Model or catalog number
88 74 427
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
C. SOMATOM Emotion Duo
Lot or serial number
37106
Model or catalog number
3813933K1521
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
D. SOMATOM Sensation 16 System - Main Unit
Lot or serial number
50128
50138
50221
50430
50487
50687
51816
51820
51853
Model or catalog number
7393114
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
E. SOMATOM Sensation/Cardiac 64
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
83 77 520
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY