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Millennium VG Variable Geometry Dual Detector Gamma Camera and VariCam (2017-10-30)
- Starting date:
- October 30, 2017
- Posting date:
- November 22, 2017
- 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-65194
Affected products
A. Millennium VG Variable Geometry Dual Detector Gamma Camera
B. VARICAM
Reason
A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan. There have been no injuries reported as a result of this issue.
Affected products
A. Millennium VG Variable Geometry Dual Detector Gamma Camera
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
H2505SA
Companies
- Manufacturer
-
GE Medical Systems Israel,
Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL
B. VARICAM
Lot or serial number
10158
10332
Model or catalog number
ASM000085
ASM001083
Companies
- Manufacturer
-
GE Medical Systems Israel,
Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL