FDR Visionary Suite
Brand(s)
Last updated
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Shimadzu Corporation
1, Nishinokyo-Kuwabaracho, Nakagyo-Ku, Kyoto-Fu, Japan, 604-8511
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Recall date
Identification number
RA-81686
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