Shimadzu FDR Visionary Suite Health Product Recall

Health Canada Recalls & Safety Alerts

Filed February 10th, 2026

Detected March 6th, 2026

Summary

Health Canada has issued a Type II recall for Shimadzu Corporation's FDR Visionary Suite medical device due to a potential safety issue with the X-ray high voltage generator. The issue could lead to overheating and smoke. Healthcare providers are advised to contact the manufacturer for more information.

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What changed

Health Canada has issued a Type II health product recall for the FDR Visionary Suite, manufactured by Shimadzu Corporation. The recall identifies a potential safety issue where the electromagnetic contactors in the X-ray high voltage generator may weld, causing continuous current supply even when the device is powered off. This could lead to overheating, damage to surrounding parts, and potentially smoke.

Healthcare providers using the FDR Visionary Suite are advised to contact Shimadzu Corporation for additional information. While no specific compliance deadline or penalty is mentioned, the nature of the defect necessitates prompt attention to ensure patient and operator safety and to prevent equipment damage. This recall highlights the importance of rigorous maintenance and adherence to manufacturer guidelines for medical imaging equipment.

What to do next

Review the FDR Visionary Suite for the described defect.
Contact Shimadzu Corporation for additional information and guidance.
Ensure proper maintenance and operational checks for medical imaging equipment.

Source document (simplified)

Health product recall

FDR Visionary Suite

Brand(s)

Shimadzu Corporation

Last updated

2026-03-05

Summary

Product FDR Visionary Suite Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.

Audience Healthcare Industry

Affected products

| Affected products | Lot or serial number | Model or catalogue number |
| --- | --- | --- |
| FDR Visionary Suite | Serial number: MP95A9E9C001 | MP95A9E9C001 |

Issue

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.