Z-1501-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 9, 2025
- Initiation Date
- February 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1876 units
Product Description
Phoroptor VRx Digital Refraction System Model Numbers: 16242
Reason for Recall
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Distribution Pattern
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: 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.