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Health product recall

Sonialvision G4

Starting date:
December 30, 2016
Posting date:
January 18, 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-61838

Reason

The issue is related to the operation for prolonged periods of time at low rate serial exposure, where the heat load capacity of the x-ray anode disc (target) may become damaged and may lead to insulating oil leaking out from the x-ray tube.

Affected products

Sonialvision G4

Lot or serial number

M1C356453010

Model or catalog number

0.7/1.2JG326D-265

Companies

Manufacturer
Shimadzu Corporation
1, Nishinokyo-Kuwabaracho
Nakagyo-Ku
604-8511
JAPAN