URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Published March 8, 2017 · Recall initiated: December 12, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- Distributed Nationwide
- Lot
- All serial numbers are affected.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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