Reichert, Inc. is recalling 87 units of the PHOROPTOR VRx Digital Refraction System because the Phoroptor head may detach from its mounting bracket. This equipment is used by eye care professionals to measure refractive errors of the eye. The recall affects Model 16242, which includes specific prism features, and the base Model 16241. If the head detaches from the ophthalmic stand, it can fall without warning, potentially striking anyone beneath it. This recall was initiated voluntarily by the firm and expanded in July 2024 to include additional units.
The Phoroptor VRx Head can spontaneously detach from the bracket that connects it to the ophthalmic stand, causing the heavy device to fall. This poses a significant risk of impact injuries to both the patient being examined and the device operator.
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Sources: FDA iRES ยท Raw API Response
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