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Millenium, Hawkeye, Hawkeye 4, and Infinia Gamma Cameras (June 14, 2013)
- Starting date:
- June 14, 2013
- Posting date:
- June 14, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-34629
Reason
GE Healthcare (GEHC) became aware of an incident associated with patient death due to injuries sustained while being scanned on an Infinia Hawkeye 4 due to a portion of the system falling onto the patient during the scan.
GEHC has been able to determine the cause of this incident. Bolts securing the camera to the gantry were loose, thereby stressing the support mechanism and resulting in the incident. The safety concern is related to a potential patient entrapment or crush hazard if the camera falls during a patient exam.
GEHC has included multiple devices due to similarities in basic mechanical concepts between these devices and the infinia systems. GEHC recommended that site cease use of nuclear medicine systems until an inspection of system by GEHC can be completed.
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
H3000YA
Companies
- Manufacturer
- Not Applicable
B. Hawkeye 4 Option for Dual Head Variable Angle Gamma Camera
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
H3000WC/WD
Companies
- Manufacturer
- Not Applicable
C. Hawkeye Option for Dual Head Variable Angle Gamma Camera
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
H3000WW
Companies
- Manufacturer
- Not Applicable
D. Infinia Dual Detector Gamma Camera
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
H3000WT
Companies
- Manufacturer
- Not Applicable
E. Discovery NM/CT 670 System - NM Gantry
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
5376204-XX
Companies
- Manufacturer
- Not Applicable
F. Discovery NM 630 System - Main Unit
Lot or serial number
00000000022051
Model or catalog number
H3100RC
Companies
- Manufacturer
- Not Applicable
- Date modified: