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U.S. Department of Health and Human Services

Class 2 Device Recall Video Cystoscope models ECY1570 and ECY1570K

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  Class 2 Device Recall Video Cystoscope models ECY1570 and ECY1570K see related information
Date Initiated by Firm July 13, 2017
Create Date February 14, 2018
Recall Status1 Terminated 3 on July 22, 2019
Recall Number Z-0615-2018
Recall Event ID 79131
Product Classification Cystoscope and accessories, flexible/rigid - Product Code FAJ
Product Video Cystoscope models ECY-1570 and ECY-1570K
Code Information 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 
Recalling Firm/
Manufacturer		 Pentax of America Inc
3 Paragon Dr
Montvale NJ 07645-1782
For Additional Information Contact Paul Silva
800-431-5880 Ext. 2064
Manufacturer Reason
for Recall		 The video cytoscopes lack 510(k) premarket notification clearance.
FDA Determined
Cause 2		 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 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
Quantity in Commerce 24
Distribution Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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