Recall Z-0264-2025 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Olympus Corporation of the Americas
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
| Date | Oct 30, 2024 (initiated Sep 4, 2024) |
| Status | Open, Classified |
| Reason | There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP). |
| Root cause | Software design |
| Action | An URGENT: MEDICAL DEVICE CORRECTIVE ACTION notification letter dated 10/1/24 was sent to customers. Actions Required: Our records indicate that your facility has received one or more affected ESG-410 (SEP) units. An Olympus representative will reach out to you to coordinate a mutually convenient time to complete a software update on your affected ESG-410 (SEP) unit(s). You may continue to use your ESG-410 (SEP) generator until the software update is completed. Additionally, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Olympus requ |
| Quantity | 279 units |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) Olympus Winter & Ibe GmbH, Aug 18, 2023 |