Z-1500-2025 Class II Ongoing

Recalled by Reichert, Inc. — Depew, NY

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
122 units

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.

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: (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.