PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended… — Class II medical device recall Z-2512-2023
Ongoing recall by Reichert, Inc., reported 2023-09-06, distributed nationwide. Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. If
| Recall number | Z-2512-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Reichert, Inc., Depew, NY, United States |
| Recall initiated | 2023-07-20 |
| Classified | 2023-08-31 |
| Reported by FDA | 2023-09-06 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00812559011730 |
| Serial numbers | 78875-0222, 78876-0222, 78877-0222, 78878-0222, 78879-0222, 78880-0222, 78881-0222, 78882-0222, 78883-0222, 78884-0222, 78885-0222, 78886-0222, 78887-0222, 78888-0222, 78889-0222, 78890-0222, 78891-0222, 78892-0222, 78893-0222, 78894-0222, 78895-0222, 78896-0222, 78897-0222, 78898-0222, 78899-0222 and 10 more |
| Model numbers | 16241, 16242 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2512-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.