FDA-Device2023-05-24Class II

Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062

Steris Corporation
Hazard

In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.

Sold states
Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: China, Lithuania, Saudi Arabia, Korea, Republic of, Canada, Taiwan, United Kingdom, Spain, Australia, New Zealand, Spain, Brazil, Bahrain, Switzerland, Great Britain, South Africa, Hong Kong, Qatar.
Affected count
322 units
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1595-2023

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