Z-0232-2025 Class II Ongoing
FDA device recall Z-0232-2025 was initiated by Olympus Corporation Of The Americas on Sep 24, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 6, 2024
- Initiation Date
- Sep 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
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.
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 Pattern
OH
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0232-2025
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026