FDAFDA · Food and drugs·Recall number Z-1500-2025
Phoroptor VRx Digital Refraction System Model Numbers: 16241
Published April 9, 2025 · Recall initiated: February 28, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Reichert, Inc.
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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