medical Class II Updated 2024-01-17

Olympus Corporation of the Americas recalls OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter

Recalled Product

OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 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 female reproductive organs.


Hazard / Issue

Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 04953170310355 All Serial Numbers
View official government recall

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