Health product recall

Sonialvision G4

Last updated

Summary

Product
Sonialvision G4
Issue
Medical devices - Software defect
What to do

Contact the importer if you require additional information.

Affected products

Affected Products Lot or Serial Number Model or catalog number
Sonialvision G4 41C351653001, 41C3534B4001 503-78000-22, 503-78000-52

Issue

Following Shimadzu's investigation, it was noted that there is a potential issue with the system software that could cause: 1) The x-ray irradiation rate (pulse rate) of pulse fluoroscopy to be different then set value, 2) The beam hardening filter during fluoroscopy to be different then set value, 3) The calculated dose displayed on the screen to be higher than actual dose (the correct does is displayed if an area dosimeter is installed). The malfunctions could lead to improper measurements of pulse rate, setting of beam hardening filter and/or inaccurate dose displayed on display screen.

Recall start date: Mar 23, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Shimadzu Corporation

1, Nishinokyo-Kuwabaracho, Nakagyo-Ku, Kyoto-Fu

Japan, 604-8511

Importer: 

CHRISTIE INNOMED

516 rue Dufour

St-Eustache, Quebec

Canada, J7R 0C3

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64042