Class 2 Device Recall Pentax Video Gastroscope

• Date Initiated by Firm: August 15, 2016
• Date Posted: October 26, 2016
• Recall Status: Terminated on April 23, 2019
• Recall Number: Z-0318-2017
• Recall Event ID: 75332
• 510(K)Number: K131902
• Product Classification: Gastroscope and accessories, flexible/rigid - Product Code FDS
• Product: Pentax Video Gastroscope 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 upper digestive tract including the esophagus, stomach and duodenum.
• Code Information: EG-1690K, EG-2490K, EG-279oI, EG-2790K, EG-2990K, EG-2990K, EG-349oK and EG-3890TK
• 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: PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.
• FDA Determined Cause: Labeling Change Control
• Action: Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers.
• Quantity in Commerce: 3,436 (US) and 14,488 (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 = FDS