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Class 2 Device Recall Phoroptor VRx Digital Refraction System |
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Date Initiated by Firm |
July 20, 2023 |
Date Posted |
August 31, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2512-2023 |
Recall Event ID |
92805 |
Product Classification |
Refractor, manual, non-powered, including phoropter - Product Code HKN
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Product |
PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: 16242 |
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
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Recalling Firm/ Manufacturer |
Reichert, Inc. 3362 Walden Ave Depew NY 14043-2437
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For Additional Information Contact |
SAME 716-686-4500
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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
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FDA Determined Cause 2 |
Device Design |
Action |
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 described, please remove it from service immediately.
Please contact our Reichert Technical Support Team at 1-888-849-8955 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
If your unit displays the defect condition described above, we will prioritize your site inspection.
Reichert will inspect and repair all units in the relevant manufacturing range. Please schedule an appointment with
Reichert even if your unit 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 to Reichert for inspection and repair. The Reichert Technical Support Team can provide you with a Return Merchandise Authorization.
Inspections and repairs will be completed at no cost to you.
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Quantity in Commerce |
50 units |
Distribution |
US Nationwide distribution. |
Total Product Life Cycle |
TPLC Device Report
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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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