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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 May 31, 2016
Create Date September 22, 2016
Recall Status1 Terminated 3 on December 21, 2017
Recall Number Z-2875-2016
Recall Event ID 74954
510(K)Number K131028  
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
Product Pentax Video Bronchoscope
Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Code Information EB-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K
Recalling Firm/
Pentax of America Inc
3 Paragon Dr
Montvale NJ 07645-1782
For Additional Information Contact Mr. Paul Silva
Manufacturer Reason
for Recall
Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.
FDA Determined
Cause 2
Packaging process control
Action Pentax Medical sent a U.S. Urgent Field Correction notice to all affected customers with a recall letter/return response form on May 31, 2016 via Fed Ex. Customers with questions were instructed to call 800-431-5880, ext. 2064.
Quantity in Commerce 1719 units
Distribution Nationwide Distribution
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 = EOQ and Original Applicant = PENTAX MEDICAL COMPANY