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U.S. Department of Health and Human Services

Class 2 Device Recall Phoroptor VRx Digital Refraction System

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 Class 2 Device Recall Phoroptor VRx Digital Refraction Systemsee related information
Date Initiated by FirmJuly 20, 2023
Date PostedAugust 31, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2512-2023
Recall Event ID 92805
Product Classification Refractor, manual, non-powered, including phoropter - Product Code HKN
ProductPHOROPTOR 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].
Code Information 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 78856-0122 78857-0122 78858-0122 78859-0122 78860-0122 78861-0122 78862-0122 78863-0122 78864-0122 78865-0122 78866-0122 78867-0122 78868-0122 78870-0122 78871-0122 78872-0122 78873-0122 78874-0122 S/N Extended Recall 7/3/24: Serial Number 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 78900-0222 78901-0222 78902-0222 78903-0222 78904-0222 78905-0222 78906-0222 78907-0222 78908-0222 78909-0322
Recalling Firm/
Manufacturer		 Reichert, Inc.
3362 Walden Ave
Depew NY 14043-2437
For Additional Information ContactSAME
716-686-4500
Manufacturer 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
FDA Determined
Cause 2		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 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
Quantity in Commerce53 units; Extended 34 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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