Reichert, Inc. is recalling 1,998 units of the Phoroptor VRx Digital Refraction System because the phoroptor head may become loose and detach during use. This issue stems from an assembly defect that could lead to the device head falling unexpectedly. No injuries have been reported at this time.
The head of the refraction system can detach from its mount due to a manufacturing assembly error. If the heavy device head falls during an examination, it could strike a patient or healthcare provider, causing physical impact injuries.
Recall #: Z-1500-2025; The majority of units within the scope are older devices which do not have a UDI on the label.
Recall #: Z-1501-2025; The majority of units within the scope are older devices which do not have a UDI on the label.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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