Olympus Quest Spectrum 3 Fluorescent Imaging System Recalled for EMC Defect
Olympus is recalling three Quest Spectrum 3 Fluorescent Imaging Systems in Ohio because they do not meet electromagnetic compatibility standards, which could cause malfunction during procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could cause malfunction during a procedure, potentially leading to prolonged procedures or additional medical intervention. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling three units of the Quest Spectrum 3 Fluorescent Imaging System (Model/Catalog Numbers ART-SYS-0029 and ART-SYS-0030). The affected devices are used in plastic and reconstructive surgeries to capture fluorescent images for assessing blood flow and tissue perfusion. The recall is limited to units distributed in Ohio.
The recall is due to the devices not meeting 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 malfunction could potentially result in a prolonged procedure and/or require additional medical intervention.
Healthcare facilities and users should stop using the affected units and contact Olympus Corporation of the Americas for instructions on replacing the devices. The specific serial numbers affected are ART-SYS-2022-F04, ART-SYS-2022-A06, and ART-SYS-2022-F05 for Model ART-SYS-0029, and all units of Model ART-SYS-0030.
The recalled product
- 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…
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Imaging System
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distribution
Distributed in 1 state:
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