Olympus Corporation of the Americas: Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand i

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide - US Nationwide distribution. Quantity: WA50040A : 561 units; WA50042A: 857 units Lot/code info: UDI-DI: WA50040A: 04042761074964 WA50042A: 04042761074971 All Serial Numbers

UPC codes

04042761074964, 04042761074971

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.