Class 2 Device Recall TRACHEAL INTUBATION FIBERSCOPE

• Date Initiated by Firm: September 28, 2023
• Date Posted: December 14, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0557-2024
• Recall Event ID: 93433
• 510(K)Number: K981543
• Product Classification: Bronchoscope (flexible or rigid) - Product Code EOQ
• Product: TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
• Code Information: UDI-DI: 04953170340215 & UDI-DI: 04953170061998. Serial numbers: 2515143, 2515181, 2515449, 2515549, 2615760, 2615761, 2615763, 2615825, 2615830, 2615831, 2616057, 2616130, 2616199, 2716417, 2817430, 2917855, 2917867, 2917997, 2918003, 2918010, 2918012, 2918030, 2018337, 2018435, 2018486, 2018543, 2018571, 2018675, 2319768, 2319820, 2510582, 2621001.
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: Cynthia Ow; 647-999-3203
• Manufacturer Reason for Recall: Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.
• FDA Determined Cause: Under Investigation by firm
• Action: An Urgent Medical Device notification dated November 1, 2023 issued via UPS Ground. The notice advises customers to examine inventory for affected serial numbers and quarantine affected product. Contact Olympus Customer Solutions Team (1-800-848-9024, option 3) to arrange for for return. Olympus will inspect and repair if necessary. Customers are to forward notice to any facility affected product may have been transferred to. Olympus requests that you acknowledge receipt of this letter with Tara.Safi@Olympus.com.
• Quantity in Commerce: 75
• Distribution: Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA, GA, IL, IN, MA, MD, MI, NC, NJ, OH, TX, UT, VA, WA, WV & AP (Armed Forces Pacific) and the countries of OUS: EMEA, Japan and Australia.
• 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