# FDA recall Z-2512-2023

> **Reichert, Inc.** · Class II · device recall initiated 2023-07-20.

## 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].

## Reason for recall

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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2512-2023
- **Recalling firm:** Reichert, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-20
- **Report date:** 2023-09-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Depew, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2512-2023

## Citation

> AI Analytics. FDA recall Z-2512-2023. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-2512-2023. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*