medical Class II Updated 2024-01-17

Olympus Corporation of the Americas recalls Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA5

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: WA50040A: 04042761074964 WA50042A: 04042761074971 All Serial Numbers
View official government recall

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