Recall Z-2512-2023 ยท HKN Refractor, Manual, Non-Powered, Including Phoropter
Reichert, Inc.
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].
| Date | Aug 31, 2023 (initiated Jul 20, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Device Design |
| Action | UPDATE July 2024: Reichert issued URGENT MEDICAL DEVICE CORRECTION PROMPT ATTENTION REQUIRED to US distributors and direct account holders via email and Fed'x on 7/3/24 about the extended recall and requested that they return end customer location information to us. Please contact our Reichert Technical Support Team at 1-888-849-8955 or at reichert.support@ametek.com immediately to schedule an appointment with the Reichert Service Team. A Reichert Service Team Member will visit your location, inspect your unit(s), and make any necessary repairs. Below is the Return Merchandise Authorizati |
| Quantity | 53 units; Extended 34 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.