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U.S. Department of Health and Human Services

Class 2 Device Recall EVIS EXERA II COLONOVIDEOSCOPE

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  Class 2 Device Recall EVIS EXERA II COLONOVIDEOSCOPE see related information
Date Initiated by Firm January 11, 2024
Date Posted February 29, 2024
Recall Status1 Open3, Classified
Recall Number Z-1214-2024
Recall Event ID 93832
510(K)Number K100584  
Product Classification Endoscope, accessories, narrow band spectrum - Product Code NWB
Product Colonoscope, Model Number PCF-Q180AL.
Code Information Model Number: PCF-Q180AL; UDI DI: 4953170307720; Serial Number: 2200140, 2603268, 2808983, 2909332;
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact Cynthia Ow
484-896-5000
Manufacturer Reason
for Recall		 Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On January 11, 2024, the firm notified customers of the issue via URGENT MEDICAL DEVICE REMOVAL letters. Customers were instructed to inspect your inventory and identify any products of the model and lots subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and stop using the device. Customers were given detailed instructions on how to identify affected product. Our Olympus Customer Solutions team will contact you to arrange a no-charge return, and a loaner as necessary. Olympus will perform an inspection of your device, repair the variable stiffness mechanism if required, and return your device at no charge to you. Please acknowledge receipt of this matter through the recall portal at https://olympusamerica.com/recall, Enter the recall number "0437" and complete the form as instructed. Customers who have further distributed product should notify downstream accounts at once. Please report to Olympus any adverse events and/or irregularities with the use of the devices by contacting the Olympus Technical Assistance Center at 1- 800-848-9024, option 1. Adverse events experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. If you have questions about this recall, please contact the recalling firm at (647) 999-3203 or by e-mail at Cynthia.Ow@Olympus.com.
Quantity in Commerce 4
Distribution US Nationwide distribution.
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 = NWB and Original Applicant = OLYMPUS MEDICAL SYSTEMS CORPORATION
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