Olympus Corporation of the Americas: Olympus Electrosurgical Generator Recalled for Audio Buffer System Error

What You Should Do

1. Identify if your facility uses the Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U with UDI-DI: 04042761087698.
2. Check the serial number on the device to see if it matches any of the 279 affected units, which include: 101698, 102191, 102706, 103016, 103068, 103112, 103161, 103199, 101702, 102195, 102707, 103018, 103069, 103114, 103162, 103200, 101920, 102197, 102709, 103019, 103072, 103115, 103163, 103201, 101923, 102266, 102710, 103020, 103073, 103116, 103165, 103203, 101925, 102427, 102711, 103025, 103074, 103117, 103166, 103206, 101929, 102660, 102712, 103026, 103075, 103119, 103167, 103207, 101932, 102661, 102713, 103029, 103076, 103120, 103168, 103208, 101933, 102664, 102714, 103030, 103077, 103121, 103169, 103209, 101934, 102665, 102715, 103031, 103078, 103122, 103170, 103210, 101937, 102668, 102716, 103033, 103080, 103123, 103172, 103211, 101945, 102672, 102717, 103034, 103081, 103124, 103173, 103212, 101947, 102673, 102718, 103035, 103082, 103125, 103174, 103214, 102149, 102674, 102719, 103037, 103083, 103126, 103176, 103215, 102150, 102678, 102721, 103041, 103084, 103127, 103177, 103216, 102153, 102679, 102722, 103042, 103085, 103132, 103178, 103217, 102154, 102681, 102723, 103043, 103087, 103133, 103179, 103218, 102155, 102682, 102724, 103044, 103088, 103134, 103180, 103219, 102156, 102683, 102993, 103045, 103089, 103135, 103181, 103220, 102159, 102684, 102994, 103046, 103091, 103136, 103182, 103221, 102161, 102685, 102995, 103047, 103092, 103137, 103183, 103222, 102162, 102686, 102996, 103048, 103094, 103139, 103184, 103223, 102163, 102687, 102997, 103049, 103095, 103140, 103185, 103224, 102164, 102688, 102998, 103050, 103096, 103141, 103186, 103225, 102167, 102689, 102999, 103051, 103097, 103142, 103187, 103228, 102168, 102691, 103000, 103052, 103098, 103143, 103188, 103583, 102172, 102692, 103001, 103053, 103099, 103144, 103189, 103584, 102173, 102693, 103002, 103056, 103100, 103149, 103190, 103585, 102176, 102694, 103003, 103059, 103101, 103150, 103191, 103587, 102178, 102695, 103004, 103060, 103102, 103152, 103192, 103791, 102183, 102697, 103006, 103061, 103103, 103153, 103193, 103796, 102184, 102698, 103007, 103062, 103104, 103155, 103194, 103802, 102185, 102699, 103008, 103063, 103108, 103156, 103195, 103812, 102187, 102700, 103012, 103064, 103109, 103158, 103196, 103832, 102189, 102702, 103013, 103066, 103110, 103159, 103197, 103833, 102190, 102705, 103014, 103067, 103111, 103160, and 103198.
3. Immediately contact Olympus Corporation of the Americas or your healthcare facility's equipment manager for further instructions and information on technical support or potential repair of the affected units.
4. If you have additional questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products