FDA-Device2017-03-08Class II
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Olympus Corporation of the Americas
Hazard
Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were stuck inside of patients that had to be surgically removed. In an effort to mitigate a potential risk to patient health, Olympus is undertaking this action to notify users of these complaints and the need for careful inspection of the endoscope prior to use in accordance with the instructions provided int heir notification letter.
Sold states
Distributed Nationwide
Affected count
3461 units distributed to US consignees
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1251-2017Don't want to check this manually?
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