FDA recall Z-0615-2018
Pentax of America Inc · Class II · device
Product
Video Cystoscope models ECY-1570 and ECY-1570K
Reason for recall
The video cytoscopes lack 510(k) premarket notification clearance.
Distribution
Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.
Key facts
- Status
- Terminated
- Initiation date
- 2017-07-13
- Report date
- 2018-02-21
- Termination date
- 2019-07-22
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Montvale, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0615-2018