FDA Device recall Z-2512-2023
PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye
- FDA Device
- Class II
- ongoing
- Published 2023-09-06
On 2023-09-06 the FDA classified a Class II recall of PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye by Reichert, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2512-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-20 |
| Published | 2023-09-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Reichert |
| Distribution | US |
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
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
Identifiers
| code_info | GTIN: 0812559011730 S/N: 78824-1221 78825-1221 78826-1221…GTIN: 0812559011730 S/N: 78824-1221 78825-1221 78826-1221 78827-1221 78828-1221 78829-1221 78830-1221 78831-1221 78832-1221 78833-1221 78834-1221 78835-1221 78836-1221 78837-1221 78838-1221 78839-1221 78840-1221 78841-1221 78842-1221 78843-1221 78844-1221 78845-1221 78846-1221 78847-1221 78848-1221 78849-1221 78850-1221 78851-1221 78852-1221 78853-0122 78854-0122 78855-0122 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2512-2023%22
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