Recall Z-0615-2018 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
Pentax of America Inc
Video Cystoscope models ECY-1570 and ECY-1570K
| Date | Jul 13, 2017 |
| Status | Terminated |
| Reason | The video cytoscopes lack 510(k) premarket notification clearance. |
| Root cause | No Marketing Application |
| Action | 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 actio |
| Quantity | 24 |
| Distribution | Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.