FDAFDA · Food and drugs·Recall number Z-0615-2018
Video Cystoscope models ECY-1570 and ECY-1570K
Published February 21, 2018 · Recall initiated: July 13, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The video cytoscopes lack 510(k) premarket notification clearance.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Pentax of America Inc
- Distributor
- Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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