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U.S. Department of Health and Human Services

Class 2 Device Recall BFXP160F EVIS EXERA Bronchovideoscope

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  Class 2 Device Recall BFXP160F EVIS EXERA Bronchovideoscope see related information
Date Initiated by Firm August 16, 2021
Create Date September 24, 2021
Recall Status1 Terminated 3 on March 11, 2024
Recall Number Z-2569-2021
Recall Event ID 88562
510(K)Number K033225  
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
Product BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
Code Information All serial numbers
Recalling Firm/
Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
For Additional Information Contact Laura Storms
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 2
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 644
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 and Original Applicant = OLYMPUS OPTICAL CO., LTD.