Rappel de produits de santé

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