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Various Biograph mCT-S Devices (2014-06-23)
- Starting date:
- June 23, 2014
- Posting date:
- July 10, 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-40427
Recalled Products
A) Biograph mCT-S with True V (64)
B) Biograph mCT-S (40)
C) Biograph mCT-S with true v (40)
Reason
Siemens is informing customers via a customer advisory letter, that their Biograph MCT or MCT flow system (with Petsyngo VG40x or VG50a software installed), could experience an intermittent pet attenuation corrected image artifact, which may impact the ability to obtain reliable data from the resulting image.
Affected products
A) 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
B) 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
C) 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