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Fdr visionary suite

Official notice

5 Mar 2026

Last checked

5 Mar 2026

Medium riskHealth Canada

An official Health Canada notice concerns Fdr visionary suite. Potential safety issue with the X-ray high voltage generator incorporated into the FDR Visionary Suite X-ray diagnostic equipment. It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator may weld, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it is possible that the circuit in question overheats and damages the surrounding parts. It may also cause smoke. Published 2026-03-05.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81686

Official notice

2026-03-05

The hazard

Potential safety issue with the X-ray high voltage generator incorporated into the FDR Visionary Suite X-ray diagnostic equipment. It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator may weld, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it is possible that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.

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.

Lots

Serial number: MP95A9E9C001

Skus

MP95A9E9C001

Other

RA RA-81686

Model Numbers

MP95A9E9C001

Recall Numbers

81686

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Affected products

Product 1

Lot or serial number - Serial number: MP95A9E9C001, Model or catalogue number - MP95A9E9C001

Risk / hazard

Potential safety issue with the X-ray high voltage generator incorporated into the FDR Visionary Suite X-ray diagnostic equipment. It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator may weld, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it is possible that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Shimadzu.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

81686

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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