—#210213

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.

FDA product code: OWN — Confocal Optical Imaging
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K143474
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: OH

Timeline

Recall initiated: 2024-09-24
Posted by FDA: 2024-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210213. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.