Olympus Corporation of the Americas recalls Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a f…

Recall date

September 24, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0232-2025

FDA classification

Class II

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

OH

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.