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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/Surgical Equipment

Olympus Quest Spectrum 3 Imaging System Recalled for Interference Risk

Agency Publication Date: October 25, 2024
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Summary

Olympus Corporation of the Americas has recalled 3 units of the Quest Spectrum 3 Fluorescent Imaging System because the device may malfunction when exposed to electromagnetic interference. This system is used by surgeons to visualize blood flow during plastic and reconstructive surgeries. If the device fails during a procedure, it could lead to surgical delays or require additional medical intervention to complete the surgery safely.

Risk

The device does not meet international standards for electromagnetic compatibility, meaning other electronic equipment could cause it to stop working. A malfunction during surgery could result in prolonged anesthesia for the patient or the need for additional medical steps to assess tissue health.

What You Should Do

  1. This recall involves the Quest Spectrum 3 Fluorescent Imaging System, Model ART-SYS-0029 and Model ART-SYS-0030.
  2. Check the device label or packaging for model numbers ART-SYS-0029 or ART-SYS-0030 and serial numbers ART-SYS-2022-F04, ART-SYS-2022-A06, or ART-SYS-2022-F05.
  3. Identify the product using the Unique Device Identifier (UDI-DI) 08719324487047.
  4. Stop using the recalled device immediately.
  5. Contact Olympus Corporation of the Americas or your equipment distributor to arrange for the return, replacement, or correction of the device.
  6. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Quest Spectrum 3 Fluorescent Imaging System
Model / REF:
ART-SYS-0029
Serial Numbers:
ART-SYS-2022-F04
ART-SYS-2022-A06
ART-SYS-2022-F05
UDI:
08719324487047

Used for visual assessment of blood flow and tissue perfusion during plastic and reconstructive surgeries.

Product: Quest Spectrum 3 Fluorescent Imaging System
Model / REF:
ART-SYS-0030
UDI:
08719324487047

No distribution reported in the USA for this model.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95423
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Olympus Corporation of the Americas
Manufactured In: United States
Units Affected: 3 units
Distributed To: Ohio

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.