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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 January 11, 2011
Create Date June 09, 2017
Recall Status1 Open3, Classified
Recall Number Z-2324-2017
Recall Event ID 77310
510(K)Number K131028  K131946  
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
Product Video Bronchoscope
Code Information Model #'s: EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970AK, EB-1970K, EB-1970TK and EB-1970UK
Recalling Firm/
Manufacturer
Pentax of America Inc
3 Paragon Dr
Montvale NJ 07645-1782
For Additional Information Contact Mr. Paul Silva
973-628-2199
Manufacturer Reason
for Recall
This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.
FDA Determined
Cause 2
Device Design
Action Customers were visited by members of Pentax America, Inc. field service team. The field service technicians inspected the affected devices, and documented the inspections using the Inspection Record Form (QS-397).
Quantity in Commerce 1,349 - (Total - US) and 352 (Total - OUS)
Distribution US Nationwide and Internationally
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = EOQ and Original Applicant = PENTAX MEDICAL COMPANY
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