# FDA recall Z-0232-2025

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2024-09-24.

## 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

## Distribution

OH

## Key facts

- **Recall number:** Z-0232-2025
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-24
- **Report date:** 2024-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0232-2025

## Citation

> AI Analytics. FDA recall Z-0232-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0232-2025. Source: US FDA. Licensed CC0.

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