Reported Mar 8, 2017 · Terminated
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-0610
Is this the product you have?
- URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
- Lot codes and dates
- All serial numbers are affected.
- Amount recalled
- 3461 units distributed to US consignees
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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