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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Reichert, Inc.: Phoroptor VRx Digital Refraction System Recalled for Detachment and Fall Risk

Agency Publication Date: August 31, 2023
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Summary

Reichert, Inc. is recalling 87 units of the PHOROPTOR VRx Digital Refraction System because the Phoroptor head may detach from its mounting bracket. This equipment is used by eye care professionals to measure refractive errors of the eye. The recall affects Model 16242, which includes specific prism features, and the base Model 16241. If the head detaches from the ophthalmic stand, it can fall without warning, potentially striking anyone beneath it. This recall was initiated voluntarily by the firm and expanded in July 2024 to include additional units.

Risk

The Phoroptor VRx Head can spontaneously detach from the bracket that connects it to the ophthalmic stand, causing the heavy device to fall. This poses a significant risk of impact injuries to both the patient being examined and the device operator.

What You Should Do

  1. Locate the serial number on your Phoroptor VRx Head to determine if your unit is affected. The initial recall affects serial numbers 78824-1221 through 78852-1221, and 78853-0122 through 78874-0122.
  2. Check for extended recall serial numbers if your unit was manufactured later: 78875-0222 through 78908-0222, and 78909-0322.
  3. Verify the Model Number is 16242 (or the base Model 16241) and the GTIN is 0812559011730.
  4. If your serial number matches the affected list, contact Reichert, Inc. immediately at their Depew, New York facility to arrange for inspection or repair instructions.
  5. Consult with your healthcare provider or clinic manager to discuss the safety of continued use while awaiting repair.
  6. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for further instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: PHOROPTOR VRX DIGITAL REFRACTION SYSTEM (Model 16242/16241)
Model / REF:
16242
16241
UPC Codes:
0812559011730
Lot Numbers (85):
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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92805
Status: Active
Manufacturer: Reichert, Inc.
Sold By: authorized distributors
Manufactured In: United States
Units Affected: 53 units; Extended 34 units
Distributed To: Nationwide
Agency Last Updated: July 15, 2024

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.