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Sonialvision g4
Official notice
12 Apr 2022
Last checked
12 Apr 2022
An official Health Canada notice concerns Sonialvision g4. 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 Published 2022-04-12.
What to do now
Contact the importer if you require additional information.
Recall number
64042
Official notice
2022-04-12
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Shimadzu, Sonialvision G4.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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