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E.CAM and Symbia Imaging Systems and Accessories (2016-03-28)
- Starting date:
- March 28, 2016
- Posting date:
- April 7, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-57844
Affected products
A. E.CAM SIGNATURE SERIES
B. SYMBIA T SERIES GAMMA CAMERA/CT SCANNERS
C. SYMBIA E DUAL HEAD SYSTEM
D. SYMBIA S
E. SYMBIA INTEVO
Reason
Siemens has determined that E. CAM or Symbia systems with foresight detectors performing gated or dynamic acquisitions may lose some detector time-information. This means that the framing of the image data and the calculated ejection fraction values may be lower.
Affected products
A. E.CAM SIGNATURE SERIES
Lot or serial number
More than 10 numbers, contact manufacturer.
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 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 Group,
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES
C. SYMBIA E DUAL HEAD SYSTEM
Lot or serial number
More than 10 numbers, contact manufacturer.
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
D. SYMBIA S
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
8717741
Companies
- Manufacturer
-
Siemens Medical Solutions USA Inc.
Molecular Imaging Group,
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES
E. 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 Group,
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES