FDA recall Z-2519-2018
Olympus Corporation of the Americas · Class II · device
Product
Uretero-reno fiberscope URF-P6
Reason for recall
Breakage of the endoscope's insertion tube bending section during surgical procedures.
Distribution
US Nationwide. Canada and Mexico
Key facts
- Status
- Terminated
- Initiation date
- 2018-01-17
- Report date
- 2018-08-01
- Termination date
- 2019-12-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Center Valley, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2519-2018