Health product recall

Sonialvision G4

Last updated

Summary

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

Contact the manufacturer 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

As a result of Shimadzu investigation, it was determined that there is an issue with the adjustment procedure documented for the calibration of the system x-ray generator. This could cause x-ray radiation dose rate to exceed regulation and/or standards.

Recall start date: Feb 9, 2022

Additional information

Details
Original published date: 2022-02-22
Alert / recall type
Health product recall
Category
Health product - Medical device - Radiology
Companies

Shimadzu Corporation

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

Japan, 604-8511

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63939