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Terminated

Video Cystoscope models ECY-1570 and ECY-1570K

FDA Recall Z-0615-2018 · Posted None

Recalling FirmPentax of America Inc
Recall StatusTerminated
Product CodeFAJ
Date Initiated2017-07-13
Date Terminated2019-07-22
Product Quantity24

Reason for Recall

The video cytoscopes lack 510(k) premarket notification clearance.

Firm 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 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: [email protected]

Root Cause

No Marketing Application

Distribution Pattern

Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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