Phoroptor VRx Digital Refraction System Model Numbers: 16241
FDA Recall #Z-1500-2025 — Class II — February 28, 2025
Product Description
Phoroptor VRx Digital Refraction System Model Numbers: 16241
Reason for Recall
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Recalling Firm
Reichert, Inc. — Depew, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
122 units
Distribution
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.
Code Information
Model Numbers: (1) 16241; UDI-DI: (1) 00812559011716; Serial Numbers: TBD; Note: The majority of units within the scope of the planned recall are older devices which do not have a UDI on the label.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated