Sonialvision G4
Brand(s)
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:
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
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63939
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