FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: 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.
- Recall number
- Z-0232-2025
- Recalling firm
- Olympus Corporation of the Americas
- 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.
- Status
- Open, Classified
- Initiated
- 2024-09-24
- Posted
- 2024-10-25
- Terminated
- not on file
- Reason
- 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
- Root cause
- Component design/selection
- Action
- Olympus issued Urgent Medical Correction letter to Operating Room Director, Risk Management on 9/24/24. Letter states reason for recall, health risk and action to take: 1. Carefully read the content of this notification. 2. Quarantine and mark you Spectrum 3 unit appropriately to prevent usage. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification. 4. Acknowledge receipt of this letter through the Olympus recall portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number "0456 c. Complete the form as instructed. 5. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints or any associated injuries to the Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@Olympus.com.
- Quantity
- 3 units
- Distribution
- OH
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K143474"]
- PMA numbers
- not on file
- Product code
- OWN
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28