BIOGRAPH MCT and BIOGRAPH HORIZON System (2018-10-19)
- Starting date:
- October 9, 2019
- Posting date:
- October 25, 2019
- 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-71385
Last updated: 2019-10-25
Affected Products
- BIOGRAPH MCT-S WITH TRUE V (64)
- BIOGRAPH MCT-S (40)
- BIOGRAPH MCT-S WITH TRUE V (40)
- BIOGRAPH MCT FLOW-3R
- BIOGRAPH MCT FLOW-4R
- BIOGRAPH MCT FLOW EDGE-4R
- BIOGRAPH MCT-S (20)
Reason
Siemens Medical Solutions USA Inc., Molecular imaging determined there is potential that the screws to the system power connection terminal may be loose. The issue affects BIOGRAPH MCT and BIOGRAPH HORIZON systems. Siemens Healthineers is initiating a field action to inspect potentially affected systems and ensure the power connector screws are torqued to the proper specification.
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
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 TRUE V (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
- 11010
- 60036
Model or catalog number
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
- 11002
- 21147
Model or catalog number
- 10507786
- 10529159
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES