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Health product recall

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