Video Cystoscope models ECY-1570 and ECY-1570K
- Company
- Pentax Of America Inc
- Recall Initiated
- July 13, 2017
- Terminated
- July 22, 2019
- Recall Number
- Z-0615-2018
- Quantity
- 24
- Firm Location
- Montvale, NJ
Reason for Recall
The video cytoscopes lack 510(k) premarket notification clearance.
Distribution
Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.
Lot / Code Info
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
Root Cause
No Marketing Application
Action Taken
Customer Instructions: Customers should inspect their stock of PENTAX Medical ECY-1570 and ECY-1570K video cystoscopes, quarantine them, and discontinue use of these products. If you have sold and distributed these products, please provide a copy of the notice and response form to the new owners. Enclosed with this letter is a customer response form. The form identifies the affected endoscopes (model and serial numbers) which have been sold to your facility. The attached form should be completed and returned to PENTAX Medical. Contact Information: If you have any questions regarding this action, please feel free to contact PENTAX Medical Customer Service. Tel: 800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) Fax: 201-799-4063 (alternate 201-391-4189) Email: customeradvisories@pentaxmedical.com