FDA-Device2024-01-17Class II
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 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.
Olympus Corporation of the Americas
Hazard
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
Sold states
Nationwide
Affected count
271 units US
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0645-2024Don't want to check this manually?
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