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Olympus Corporation of the Americas recalls Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light sou
Recalled January 17, 2024 · FDA recall Z-0697-2024 · Olympus Corporation of the Americas
Hazard
Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur. · FDA Class II
Units
WA50040A : 561 units; WA50042A: 857 units
Sold at
Worldwide - US Nationwide distribution.
Description
Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.
Product
Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →