Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a fl
FDA device recall Z-0232-2025 · posted 2024-10-25 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- 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
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Open, Classified
- Product code
- OWN
- Quantity affected
- 3 units
- Distribution
- OH
- Date initiated
- 2024-09-24
- Date posted
- 2024-10-25
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Artemis Hand Held Imaging System (K143474) | Quest Medical Imaging | 2015-06-30 |