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Pentax of America Inc recalls Video Cystoscope models ECY-1570 and ECY-1570K
Recalled February 21, 2018 · FDA recall Z-0615-2018 · Pentax of America
Hazard
The video cytoscopes lack 510(k) premarket notification clearance. · FDA Class II
Units
24
Sold at
Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.
Description
The video cytoscopes lack 510(k) premarket notification clearance.
Product
Video Cystoscope models ECY-1570 and ECY-1570K
Manufacturer(s)
Pentax of America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →