Z-0697-2024 Class II Ongoing
FDA device recall Z-0697-2024 was initiated by Olympus Corporation of the Americas on November 6, 2023 and is designated Class II. 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 inju… The recall status is ongoing. Affected quantity: WA50040A : 561 units; WA50042A: 857 units.
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