Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2512-2023 — 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 la

U.S. FDA — Device Enforcement · United States · 2023-07-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2512-2023
Date of alert: 2023-07-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Reichert, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0812559011730

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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