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].
Recall
- Recall Number
- Z-2512-2023
- Event Number
- 92805
- Firm
- Reichert, Inc.
- FEI Number
- 1000159913
- Product Code
- HKN
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- July 20, 2023
- Posted
- August 31, 2023
- Address
- 3362 Walden Ave, Depew, NY, 14043-2437
Description
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].
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
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 [email protected] 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 Authorization (RMA) that has been assigned to your unit. Reichert will inspect and repair all units in the relevant manufacturing range. Please schedule an appointment with Reichert even if your unit(s) does not display the defect condition described above. It is necessary that ALL units be inspected by Reichert. If you prefer, you may send your unit(s) to Reichert for inspection and repair. The Reichert Technical Support Team can provide a loaner unit to you using the Return Merchandise Authorization shown above. Inspections, repairs and the loaner unit will be provided at no cost to you. __________________________________________________________________ Reichert contacted authorized distributors and direct accounts who were shipped devices within the scope of the campaign on, July 20, 2023. The letter informed them of the product correction and the need to provide Reichert with the end-user location and contact information for all affected units. The Customer Urgent Medical Device Correction - Prompt Attention Required Letter issued July 27, 2023. Letter states reason for recall, health risk and action to take: While Reichert plans a thorough inspection of all units manufactured between December 2021 and January 2022, pending completion of the Reichert visit to your location, please conduct the abbreviated inspection shown in the image below. If a unit displays the condition
US Nationwide distribution.
53 units; Extended 34 units