Class 2 Device Recall Pentax

• Date Initiated by Firm: January 11, 2011
• Create Date: June 09, 2017
• Recall Status: Terminated on March 13, 2018
• Recall Number: Z-2326-2017
• Recall Event ID: 77310
• 510(K)Number: K131028 K131946
• Product Classification: Bronchoscope (flexible or rigid) - Product Code EOQ
• Product: Video Naso pharyngo Laryngoscopes
• Code Information: Model #: VNL-1570STK
• 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: 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 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