Recall Z-0264-2025— Olympus Corporation of the Americas

Name: FDA recall Z-0264-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-04

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-09-04. It names one FDA 510(k) clearance: K231777. Product: Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U. 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)..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2024-09-04
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K231777 — Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)Olympus Winter & Ibe GmbH·cleared 2023-08-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.