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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