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Siemens Gamma Cameras (2016-03-01)
- Starting date:
- March 1, 2016
- Posting date:
- March 10, 2016
- 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-57482
Affected Products
- E.CAM SIGNATURE SERIES
- SYMBIA E DUAL HEAD SYSTEM
Reason
As a result of user error complaints regarding injuries resulting from collimator change, Siemens has determined that for E. Cam or Symbia E systems, although the existing user manual is correct, additional supplemental instructions, with the inclusion of visual aids, may further clarify and emphasize the proper collimator change process.
A customer advisory notice is being issued to advise customers that Siemens is providing an addendum to the Symbia E and E.Cam user manual with specific enhancements to the instructions for collimator change. Incidents during collimator change may be avoided by operators properly following specified instructions.
Affected products
A. E.CAM SIGNATURE SERIES
Lot or serial number
ALL
Model or catalog number
- 07333235
- 07333284
Companies
- Manufacturer
-
Siemens Medical Solutions USA Inc.
Molecular Imaging Group,
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES
B. SYMBIA E DUAL HEAD SYSTEM
Lot or serial number
SN 1012
Model or catalog number
10275879
Companies
- Manufacturer
-
Siemens Medical Solutions USA Inc.
Molecular Imaging Group,
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES