BEUDAMED
    FDA Enforcement Class II Ongoing

    Phoroptor VRx Digital Refraction System Model Numbers: 16242

    Recall: Z-1501-2025 · Reported April 9, 2025

    Enforcement

    Recall Number
    Z-1501-2025
    Event ID
    96266
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Reichert, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 9, 2025
    Initiation Date
    February 28, 2025
    Classification Date
    March 31, 2025
    Address
    3362 Walden Ave, Depew, NY, 14043-2437, United States

    Description

    Phoroptor VRx Digital Refraction System Model Numbers: 16242

    Reason

    The head of the phoropter head could come loose and potentially detach due to a default in the assembly.

    Code Info

    Model Numbers: 16242; UDI-DI: 00812559011730; 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.

    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.

    Quantity

    1876 units