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U.S. Department of Health and Human Services

Class 2 Device Recall Video Colonoscope EC34i10L Video Colonoscope EC38i10L

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  Class 2 Device Recall Video Colonoscope EC34i10L Video Colonoscope EC38i10L see related information
Date Initiated by Firm January 03, 2020
Create Date February 19, 2020
Recall Status1 Terminated 3 on January 26, 2021
Recall Number Z-1267-2020
Recall Event ID 84735
510(K)Number K131855  
Product Classification Colonoscope and accessories, flexible/rigid - Product Code FDF
Product Pentax Video Colonoscope
Model: EC34-i10L
Code Information Serial Numbers: L110300, L110301, L110303, L110306
Recalling Firm/
Manufacturer		 Pentax of America Inc
3 Paragon Dr
Montvale NJ 07645-1782
For Additional Information Contact SAME
973-628-2199
Manufacturer Reason
for Recall		 Distributed in the USA without an approved 510K
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Pentax Medical contacted US Affected Customers by telephone to inform them of the pending action and to advise they quarantine the affected products Pentax issued URGENT MEDICAL DEVICE CORRECTIONAND REMOVAL Letter via UPS dated 1/3/20 states: reason for recall, health risk and action to take: Please quarantine the units your facility owns, complete the response form, and return it to PENTAX Medical using the e-mail address or fax number listed below. Upon return of the response form, PENTAX will contact your facility to arrange the return of the affected units. Loaner units will be supplied until this issue is resolved. Question contact: 1-800-431-5880 (8:30 AM  5:00 PM, Monday  Friday, EST) Fax: 201-799-4063 (alternate 201-391-4189) Email: customeradvisories@pentaxmedical.com
Distribution NC, MA
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.
510(K) Database 510(K)s with Product Code = FDF and Original Applicant = PENTAX MEDICAL COMPANY
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