This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Biograph mCT Flow-4R (2014-07-11)
- Starting date:
- July 11, 2014
- Posting date:
- November 21, 2014
- 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-42257
Recalled products
- Biograph mCT Flow-4R
Reason
There is a potential malfunction that could occur on the Biograph mCT or Biograph MCT Flow PET/CT System. This malfunction may cause a display freeze during CT interventional procedures. This issue only occurs on systems running PETsyngo VG50A and equipped with the adaptive 3D intervention option.
Affected products
A. Biograph mCT Flow-4R
Lot or serial number
- S/N 11002
Model or catalog number
- 10529159
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc. Molecular Imaging
810 Innovation Drive
Knoxville
37932
Tennessee
UNITED STATES