FDR Visionary Suite X-ray Equipment Recalled Due to Overheating and Smoke Risk

Product & Food Recalls high Health Canada · · Canada

Shimadzu Corporation has issued a recall for FDR Visionary Suite X-ray equipment due to a defect in the high-voltage generator that can cause overheating and smoke.

What Happened

Health Canada has announced a recall involving the FDR Visionary Suite X-ray diagnostic equipment. A technical issue was identified within the X-ray high-voltage generator’s cabinet, specifically regarding the electromagnetic contactors. It was found that these contacts may weld together, allowing electrical current to continue flowing to the power supply circuit even after the device has been powered off. This malfunction can lead to the circuit overheating, damaging surrounding components and potentially producing smoke.

Which Products Are Affected

The recall affects the following specific unit of the FDR Visionary Suite:

  • Product Name: FDR Visionary Suite
  • Manufacturer: Shimadzu Corporation
  • Serial Number: MP95A9E9C001
  • Model/Catalogue Number: MP95A9E9C001

What You Should Do

Facilities using the FDR Visionary Suite should identify if their equipment matches the affected serial number. While specific consumer return instructions were not detailed in the initial notice, owners of medical diagnostic equipment typically coordinate with the manufacturer for technical service. Shimadzu Corporation is located at 1, Nishinokyo-Kuwabaracho, Nakagyo-Ku, Kyoto-Fu, Japan.

Why This Matters

This recall is significant because the failure of power-cut mechanisms in high-voltage medical equipment poses a fire hazard and risk of equipment damage, which could impact both patient safety and clinical operations.

Source

For more information, visit the official Health Canada recall notice.

Source: Health Canada Official Notice

Frequently Asked Questions

What is this product & food recalls alert about?
Shimadzu Corporation has issued a recall for FDR Visionary Suite X-ray equipment due to a defect in the high-voltage generator that can cause overheating and smoke.
Which agency issued this alert?
This alert was issued by Health Canada. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects Canada. Check with Health Canada for the most current geographic scope.
Where can I find more product & food recalls alerts?
Browse all product & food recalls alerts on Areazine at areazine.com/ca/recalls/ for the latest updates from Health Canada and other agencies.