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Reichert, Inc. recalls PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive erro

Recalled September 6, 2023 · FDA recall Z-2512-2023 · Reichert

Hazard
Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. If the Phoroptor VRx Head detaches from the bracket, it can fall onto a patient or device operator · FDA Class II
Units
53 units; Extended 34 units
Sold at
US Nationwide distribution.

Description

Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. If the Phoroptor VRx Head detaches from the bracket, it can fall onto a patient or device operator

Product
PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: 16242 [Model 16241 is the base model. Model 16242 includes an additional prism feature used for the measurement of ocular deviation in patients with latent or manifest strabismus].
Manufacturer(s)
Reichert, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Reichert, Inc. recalls PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive erro | RecallWatchUSA