Z-0615-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- July 13, 2017
- Termination Date
- July 22, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
Product Description
Video Cystoscope models ECY-1570 and ECY-1570K
Reason for Recall
The video cytoscopes lack 510(k) premarket notification clearance.
Distribution Pattern
Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.
Code Information
Serial number: J110097 J110101 G110053 G110051 G110052 G110054 G110015 G110084 H110086 H110088 J110062 G110016 G110039 G110048 G110049 G110038 J110061 G110021 J110078 G110056 G110057 G110073 G110037 G110058