Biograph mCT-S with TrueV (64) and TrueV (40), Biograph mCT-S (40) and (20), Biograph mCT Flow-3R, Flow-4R and Flow Edge-4R (2018-05-16)
- Starting date:
- May 16, 2018
- Posting date:
- June 22, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67072
Affected products
A. Biograph mCT-S with TrueV (64)
B. Biograph mCT-S (40)
C. Biograph mCT-S with TrueV (40)
D. Biograph mCT Flow-3R
E. Biograph mCT Flow-4R
F. Biograph mCT Flow Edge-4R
G. Biograph mCT-S (20)
Reason
Siemens is notifying users of Biograph Systems of an issue that could potentially impact the CARE Dose4D algorithm in CT scans that include the head. An increase in dose is possible when scanning the head region with CARE Dose4D using a Posterior-Anterior (PA) or Anterior Posterior (AP) topogram. The customer letter includes instructions to avoid the issue.
Affected products
A. Biograph mCT-S with TrueV (64)
Lot or serial number
11030
Model or catalog number
10248672
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES
B. Biograph mCT-S (40)
Lot or serial number
11044
Model or catalog number
10248668
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES
C. Biograph mCT-S with TrueV (40)
Lot or serial number
- 11058
- 11069
Model or catalog number
10248671
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES
D. Biograph mCT Flow-3R
Lot or serial number
59002
Model or catalog number
10528956
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES
E. Biograph mCT Flow-4R
Lot or serial number
- 11002
- 11010
- 60036
Model or catalog number
- 10529159
- 10529161
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES
F. Biograph mCT Flow Edge-4R
Lot or serial number
11013
Model or catalog number
10528955
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES
G. Biograph mCT-S (20)
Lot or serial number
21147
Model or catalog number
10507786
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES