FDA-Device2025-04-09Class II
Phoroptor VRx Digital Refraction System Model Numbers: 16242
Reichert, Inc.
Hazard
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Sold states
Domestic: Nationwide Distribution. International: Austria, Bolivia, Canada, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Morocco, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, Slovakia, Switzerland, Thailand, United Arab Emirates, and United Kingdom.
Affected count
1876 units
Manufactured in
3362 Walden Ave, Depew, NY, United States
Products
Phoroptor VRx Digital Refraction System Model Numbers: 16242
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1501-2025Don't want to check this manually?
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