Symbia T series Gamma Camera/CT Scanners, Symbia Intevo and Symbia Intevo Bold (2018-05-16)
- Starting date:
- May 16, 2018
- Posting date:
- June 6, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66986
Affected products
- Symbia T series Gamma Camera/CT Scanners
- Symbia Intevo
- Symbia Intevo Bold
Reason
Siemens is notifying users of Symbia T and Symbia Intevo SPECT /CT systems of an issue that could potentially impact the care Dose4D algorithm in CT scans that include the head. An increase in dose is possible when scanning the head region with care Dose4D using a Posterior-Anterior (PA) or Anterior-Posterior (AP) topogram. The customer letter includes instructions to avoid the issue.
Affected products
A. Symbia T series Gamma Camera/CT Scanners
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 08717733
- 10275007
- 10275008
- 10275009
- 10275010
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES
B. Symbia Intevo
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
10764801
10764802
10764803
10764804
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES
C. Symbia Intevo Bold
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
11007962
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES