CLASS II ONGOING Device recall · Reported 6 Nov 2024 · FDA Enforcement Report

Quest Spectrum 3 Fluorescent Imaging System recalled

Olympus Corporation of the Americas is recalling Quest Spectrum 3 Fluorescent Imaging System, distributed in Ohio. The recall was initiated on 24 Sep 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 08719324487047 Lot Code: Model: ART-SYS-0029, Serial: ART-SYS-2022-F04, ART-SYS-2022-A06, ART-SYS-2022-F05; Model: ART-SYS-0030; No distribution in the USA

Quantity recalled3 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0232-2025
FDA event ID: 95423
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 24 Sep 2024
FDA classified: 25 Oct 2024
Reported: 6 Nov 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

24 Sep 2024	Recall initiated by company
25 Oct 2024	Classified by FDA	+31 days
6 Nov 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Ohio

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 08719324487047 Lot Code: Model: ART-SYS-0029, Serial: ART-SYS-2022-F04, ART-SYS-2022-A06, ART-SYS-2022-F05; Model: ART-SYS-0030; No distribution in the USA

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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