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Millenium VG Variable Geometry Dual Detector Camera-Hawkeye, Hawkeye 4, Infinia Dual Detector Gamma Camera, Discovery NM/CT 670 and NM 630 System (2014-09-25)
- Starting date:
- September 25, 2014
- Posting date:
- October 9, 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-41685
Recalled Products
A) Millenium VG Variable Geometry Dual Detector Camera
B) Millenium VG Variable Geometry Dual Detector Camera (Hawkeye 4)
C) Millenium VG Variable Geometry Dual Detector Camera (Hawkeye)
D) Millenium VG Variable Geometry Dual Detector Camera (Infinia Dual Detector Gamma Camera )
E) Millenium VG Variable Geometry Dual Detector Camera (Discovery NM/CT 670 System)
F) Millenium VG Variable Geometry Dual Detector Camera (Discovery NM 630 System )
Reason
GE Healthcare performed a field action on GE Healthcare nuclear medicine system due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. As part of this field action, GE Healthcare updated the preventative maintenance procedure and schedule and added an additional preventative maintenance check for loose fasteners.
Affected products
A) Millenium VG Variable Geometry Dual Detector Camera
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
H3000YA
Companies
- Manufacturer
-
GE Medical Systems Israel,
Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL
B) Millenium VG Variable Geometry Dual Detector Camera (Hawkeye 4)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
H3000WC/WD
Companies
- Manufacturer
-
GE Medical Systems Israel,
Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL
C) Millenium VG Variable Geometry Dual Detector Camera (Hawkeye)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
H3000WW
H3000WZ
H3000YM
H3000YS
Companies
- Manufacturer
-
GE Medical Systems Israel,
Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL
D) Millenium VG Variable Geometry Dual Detector Camera (Infinia Dual Detector Gamma Camera )
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
H3000WT
Companies
- Manufacturer
-
GE Medical Systems Israel,
Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL
E) Millenium VG Variable Geometry Dual Detector Camera (Discovery NM/CT 670 System)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5368012
Companies
- Manufacturer
-
GE Medical Systems Israel,
Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL
F) Millenium VG Variable Geometry Dual Detector Camera (Discovery NM 630 System )
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
H3100RC
Companies
- Manufacturer
-
GE Medical Systems Israel,
Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL