Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number:… — Class II medical device recall Z-0232-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2024-11-06, distributed in OH. Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electrom
| Recall number | Z-0232-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2024-09-24 |
| Classified | 2024-10-25 |
| Reported by FDA | 2024-11-06 |
| Distributed | OH |
| Quantity | 3 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 08719324487047 |
| Serial numbers | ART-SYS-2022-A06, ART-SYS-2022-F04, ART-SYS-2022-F05 |
| Model numbers | ART-SYS-0029, ART-SYS-0030 |
Product
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0232-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.