Olympus Corporation of the Americas: Device Recall

Recall #Z-0232-2025 · 09/24/2024

Class II: Risk

Recall Details

Recall Number
Z-0232-2025
Classification
Class II
Product Type
Device
Recalling Firm
Olympus Corporation of the Americas
Status
Ongoing
Date Initiated
09/24/2024
Location
Center Valley, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units

Reason for Recall

Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the device to malfunction requiring the replacement of the device. This could potentially result in a prolonged procedure and/or require additional medical intervention

Product Description

Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic and reconstructive surgeries.

Distribution Pattern

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Other Recalls by Olympus Corporation of the Americas

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.