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U.S. Department of Health and Human Services

Class 2 Device Recall Pentax

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  Class 2 Device Recall Pentax see related information
Date Initiated by Firm August 15, 2016
Date Posted November 19, 2016
Recall Status1 Terminated 3 on March 08, 2018
Recall Number Z-0636-2017
Recall Event ID 75306
510(K)Number K131855  
Product Classification Colonoscope and accessories, flexible/rigid - Product Code FDF
Product Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
Code Information Model #'s EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC-3890LI, EC-3890LK and EC-3890TLK
Recalling Firm/
Pentax of America Inc
3 Paragon Dr
Montvale NJ 07645-1782
For Additional Information Contact Mr. Paul Silva
800-431-5880 Ext. 2064
Manufacturer Reason
for Recall
Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU's that were in use prior to the 2014 clearances and therefore did not include the cleared operation IFU, the updated reprocessing IFU or the dedicated reprocessing adaptor (for applicable models).
FDA Determined
Cause 2
Action Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers.
Quantity in Commerce 5,090 (US) and 14,209 (OUS)
Distribution US Nationwide and Japan
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