Class 2 Device Recall HF Cable WA00014A

• Date Initiated by Firm: November 03, 2016
• Create Date: December 14, 2016
• Recall Status: Terminated on February 06, 2019
• Recall Number: Z-0754-2017
• Recall Event ID: 75601
• 510(K)Number: K120418
• Product Classification: Electrode, electrosurgical, active, urological - Product Code FAS
• Product: HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
• Code Information: Model Number: WA00014A Lot Numbers: 158W, 159W, 15XW, 15YW, 15ZW, 161W, 162W, 163W, 164W, 165W, 166W, 167W
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; PO Box 610; Center Valley PA 18034-0610
• For Additional Information Contact: Laura Storms; 484-8965688
• Manufacturer Reason for Recall: Software malfunction that results in incorrect generation or display of error codes.
• FDA Determined Cause: Under Investigation by firm
• Action: Olympus mailed on 11/03/2016 an Urgent Communication Letter to customers affected by the recall. The letter requested that consignees inspect their inventory for the affected lots and call Customer Service to obtain a Returned Material Authorization (RMA) to return the product.
• Quantity in Commerce: 494 units
• Distribution: Distributed Nationwide
• 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 = FAS