Recall Z-0232-2025 ยท OWN Confocal Optical Imaging
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.
| Date | Oct 25, 2024 (initiated Sep 24, 2024) |
| Status | Open, Classified |
| 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 |
| Quantity | 3 units |
| Distribution | OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143474 | Artemis Hand Held Imaging System Quest Medical Imaging, Jun 30, 2015 |