Class 2 Device Recall Olympus BFQ180 Bronchoscope

• Date Initiated by Firm: August 31, 2020
• Create Date: September 25, 2020
• Recall Status: Terminated on February 14, 2024
• Recall Number: Z-3017-2020
• Recall Event ID: 86384
• 510(K)Number: K061313
• Product Classification: Bronchoscope (flexible or rigid) - Product Code EOQ
• Product: Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
• 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; 484-896-5000
• Manufacturer Reason for Recall: The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections than other comparable OMSC bronchoscopes.
• FDA Determined Cause: Device Design
• Action: Olympus Corporation notified direct customer accounts on 08/31/2020 via recall notification letter. Letter states reason for recall, health risk, and action to take. Actions to be taken by customers include the following: 1. Inspect your inventory and identify any BF-Q180 models. 2. Call your Olympus customer service representative at 1-888-524-7266 option 1 to make arrangements to return your BF-Q180 bronchoscope and discuss replacement options. Olympus will issue a Return Material Authorization for you to return any BF-Q180 at no charge. 3. The timing to return your BF-Q180 and receive a replacement product from Olympus will depend on existing inventory. An Olympus representative will inform you of the approximate timing for your return/replacement. 4. In recognition of the need to continue to serve patients, the BF-Q180 may be continued to be used clinically until suitable alternatives are sufficiently available. Olympus recommends continued adherence to the Instructions for Use related to reprocessing. Customers should note that the BF-Q180 has been validated for High Level Disinfection (HLD), Ethylene Oxide Sterilization and Sterrad NX. Clinical support staff is available to answer questions related to all reprocessing procedures. 5. Olympus will reimburse you $10,000 for each returned BF-Q180. 6. Access the Olympus recall portal to indicate that you have received this notification. Go to https ://olympusamerica.com/recall. Enter the recall number Recall-0366 and provide your contact information as indicated in the portal. 7. If you may have further distributed the BF-Q180, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
• Quantity in Commerce: 5,813 devices distributed worldwide, including 2,648 devices distributed throughout U.S.A.
• Distribution: Worldwide distribution - US Nationwide and International.
• 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 and Original Applicant = OLYMPUS MEDICAL SYSTEMS CORPORATION