Class 2 Device Recall BF1T180 EVIS EXERA II Bronchovideoscope

• Date Initiated by Firm: August 16, 2021
• Create Date: September 24, 2021
• Recall Status: Terminated on March 11, 2024
• Recall Number: Z-2572-2021
• Recall Event ID: 88562
• 510(K)Number: K061313
• Product Classification: Bronchoscope (flexible or rigid) - Product Code EOQ
• Product: BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
• Code Information: All serial numbers
• 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; 484-896-5688
• Manufacturer Reason for Recall: The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
• FDA Determined Cause: Reprocessing Controls
• Action: On August __, 2021, the firm distributed Urgent Medical Device Corrective Action letters to customers. The applicable addenda to the reprocessing instructions were attached to the letters. Action steps to be taken by the end user: 1. Inspect your inventory for the referenced devices and identify any device with the model names specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. 2. Carefully read the content of this Medical Device Correction Action as well as the attached Addendum . The addendum provides updated information or instructions on the chemicals to be used for reprocessing, the sterilization conditions, rinsing after high-level disinfection, and recommendation on using sterilization. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the new reprocessing steps. 4. Additional copies of the new Operation Manuals can be obtained by accessing our OlympusConnect site and downloading a copy of the new Manuals. Please visit our OlympusConnect customer website: at https://www.OlympusConnect.com New users will need to register. Once registered select [Product Support] on the left navigation bar, then select [Instruction Manuals], locate the applicable product codes and select the [Download] option. 5. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number and provide your contact information as indicated in the portal. 6. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. For further information, contact the firm's Technical Assistance Center at 1-800-848-9024, option 1.
• Quantity in Commerce: 1694
• Distribution: Domestic distribution nationwide. Product also distributed globally.
• 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