Device evidence

device-recall:cfres:145351

Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Official recall number

Z-2070-2016

Evidence summary

Product code: FAJ
Recall status: Terminated
Event initiated: April 06, 2016
Root cause: Device Design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2070-2016