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Biograh PET/CT System (2014-06-20)
- Starting date:
- June 20, 2014
- Posting date:
- September 16, 2014
- 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-41387
Recalled products
- Biograph 6 - Main Unit
- Biograph mCT-S with True V (64)
- Biograph mCT-S (40)
- Biograph mCT-S with True V (40)
- Biograph ISO 16 Slice PET
Reason
The Biograph PET/CT system could experience an issue resulting in incorrect pet quantification when metal artifact reduction (MAR) is enabled during a PET reconstruction of data acquired from non-cardiac regions.
Affected products
A. Biograph 6 - Main Unit
Lot or serial number
- 44911
Model or catalog number
- 8728854
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
810 Innovation Drive
Knoxville
37932
Tennessee
UNITED STATES
B. Biograph mCT-S with True V (64)
Lot or serial number
- 11030
Model or catalog number
- 10248672
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
810 Innovation Drive
Knoxville
37932
Tennessee
UNITED STATES
C. Biograph mCT-S (40)
Lot or serial number
- 11044
Model or catalog number
- 10248668
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
810 Innovation Drive
Knoxville
37932
Tennessee
UNITED STATES
D. Biograph mCT-S with True V (40)
Lot or serial number
- 11058
- 11069
Model or catalog number
- 10248671
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
810 Innovation Drive
Knoxville
37932
Tennessee
UNITED STATES
E. Biograph ISO 16 Slice PET
Lot or serial number
- 1052
- 1313
- 1317
- 1402
- 48450
- P0007130-0401008
Model or catalog number
- 87 28 581
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
810 Innovation Drive
Knoxville
37932
Tennessee
UNITED STATES