Video Cystoscope models ECY-1570 and ECY-1570K
Reported: February 21, 2018 Initiated: July 13, 2017 #Z-0615-2018
Product Description
Video Cystoscope models ECY-1570 and ECY-1570K
Reason for Recall
The video cytoscopes lack 510(k) premarket notification clearance.
Details
- Recalling Firm
- Pentax of America Inc
- Units Affected
- 24
- Distribution
- Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.
- Location
- Montvale, NJ
Frequently Asked Questions
What product was recalled? ▼
Video Cystoscope models ECY-1570 and ECY-1570K. Recalled by Pentax of America Inc. Units affected: 24.
Why was this product recalled? ▼
The video cytoscopes lack 510(k) premarket notification clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 21, 2018. Severity: Moderate. Recall number: Z-0615-2018.
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