Public recall detail

FDR Visionary Suite

2026-03-05

medium
Radiology Performance
Quick summary

Quick summary: FDR Visionary Suite. Reason: Performance. Category: Radiology. Date: 2026-03-05.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: FDR Visionary Suite. Reason: Performance. Category: Radiology. Date: 2026-03-05.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandShimadzu Corporation
ProductFDR Visionary Suite
IssueMedical devices - Performance
Recall classType II
IdentificationRA-81686

Affected products

ProductFDR Visionary Suite
LotSerial number: MP95A9E9C001
ModelMP95A9E9C001
Serial numberSerial number: MP95A9E9C001
DescriptionFDR Visionary Suite

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - Radiology
CompaniesShimadzu Corporation 1, Nishinokyo-Kuwabaracho, Nakagyo-Ku, Kyoto-Fu, Japan, 604-8511
Recall date2026-02-10
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81686
Background{}
CompaniesShimadzu Corporation 1, Nishinokyo-Kuwabaracho, Nakagyo-Ku, Kyoto-Fu, Japan, 604-8511
AudiencesHealthcare Industry
Source updated2026-03-05

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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