Home / Recalls / Olympus Corporation of the Americas / Z-0697-2024

Z-0697-2024 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
January 17, 2024
Initiation Date
November 6, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
WA50040A : 561 units; WA50042A: 857 units

Product Description

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.

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 Pattern

Worldwide - US Nationwide distribution.

Code Information

UDI-DI: WA50040A: 04042761074964 WA50042A: 04042761074971 All Serial Numbers

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