Biograph mCT-S (40), with True V and Flow-4R (2020-03-10)
- Starting date:
- March 10, 2020
- Posting date:
- April 16, 2020
- 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-72759
Last updated: 2020-04-16
Affected Products
- Biograph mCT-S (40)
- Biograph mCT-S with True V (40)
- Biograph mCT Flow-4R
Reason
Siemens has confirmed that in a limited number of systems with petsyngo software version VG70B1, the system may freeze or abort during pet acquisition. This may result in the need to restart the system. This issue may ultimately result in the requirement for patient rescan and delay in diagnosis. There are no steps the user can take to avoid the issue.
Affected products
A. Biograph mCT-S (40)
Lot or serial number
- 11044
Model or catalog number
- 10248668
Companies
- Manufacturer
-
Siemens Medical Solutions USA Inc.
Molecular Imaging Group,
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES
B. Biograph mCT-S with True V (40)
Lot or serial number
- 11069
Model or catalog number
- 10248671
Companies
- Manufacturer
-
Siemens Medical Solutions USA Inc.
Molecular Imaging Group,
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES
C. Biograph mCT Flow-4R
Lot or serial number
- 11002
- 11010
Model or catalog number
- 10529159
- 10529161
Companies
- Manufacturer
-
Siemens Medical Solutions USA Inc.
Molecular Imaging Group,
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES