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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 April 06, 2016
Date Posted June 28, 2016
Recall Status1 Terminated 3 on December 21, 2017
Recall Number Z-2075-2016
Recall Event ID 73894
510(K)Number K951577  K951572  
Product Classification sigmoidoscope and accessories, flexible/rigid - Product Code FAM
Product Signmoidoscope
Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations
Code Information Model #'s FS-34V, ES-3831, ES-3870K and ES-3840
Recalling Firm/
Pentax Medical Company
3 Paragon Dr
Montvale NJ 07645-1782
For Additional Information Contact Mr. Paul Silva
800-431-5880 Ext. 2064
Manufacturer Reason
for Recall
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
FDA Determined
Cause 2
Device Design
Action Pentax sent an Urgent Field Correction letter dated April 6, 2016 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were reminded to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices passed through the instrument channel are accounted for after use. If the instrument/suction channel does become blocked or clogged due to the accumulation of debris, an accessory that cannot be removed, or other cause, do NOT attempt to correct the blockage or continue to use the endoscope. Customers were instructed to contact their local PENTAX Medical Service facility to have the endoscope repaired. Customers with questions were instructed to call 800-431-5880, ext 2064.
Quantity in Commerce 1,596 units
Distribution Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, 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.
510(K) Database 510(K)s with Product Code = FAM and Original Applicant = PENTAX PRECISION INSTRUMENT CORP.