BIOGRAPH MCT SYSTEM (2019-07-22)
- Starting date:
- July 22, 2019
- Posting date:
- August 2, 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-70601
Last updated: 2019-08-02
Affected Products
A. BIOGRAPH MCT-S (40)
B. BIOGRAPH MCT-S WITH TRUE V (40)
C. BIOGRAPH MCT FLOW-4R
Reason
Biograph MCT or MCT Flow systems running petsyng VG70A software may have issues where the lSO QC (quality check) does not execute correctly on the newest system designs. Invalid time tags may result in PET scan aborts and failure of PET image reconstruction. These issues may result in the necessity for patient rescan.
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
Model or catalog number
10529159
Companies
- Manufacturer
-
Siemens Medical Solutions USA Inc.
Molecular Imaging Group,
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES