Biograph 6 - Main Unit and Biograph LSO 16 Slice PET (2018-05-16)
- Starting date:
- May 16, 2018
- Posting date:
- June 22, 2018
- 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-67074
Affected products
A. Biograph 6 - Main Unit
B. Biograph LSO 16 Slice PET
Reason
Siemens is notifying users of Biograph 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. Biograph< 6 - Main Unit
Lot or serial number
44911
Model or catalog number
87 28 854
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
810 Innovation Drive
Knoxville
37932
Tennessee
UNITED STATES
B. Biograph LSO 16 Slice PET
Lot or serial number
- 1052
- 1313
- 1317
- 1402
- 48450
- P0007130-0401006
- P0007130-0401008
Model or catalog number
87 28 581
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
810 Innovation Drive
Knoxville
37932
Tennessee
UNITED STATES