Class 2 Device Recall Olympus GIF1100

• Date Initiated by Firm: August 21, 2024
• Date Posted: October 23, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0181-2025
• Recall Event ID: 95421
• 510(K)Number: K222584
• Product Classification: Endoscopic video imaging system/component, gastroenterology-urology - Product Code FET
• Product: Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
• Code Information: UDI-DI: 04953170420191; Serial Numbes: 2304049 2404551 2404550 2404541 2404537 2404577 2404576 2404574 2404571 2404570 2404569 2404568 2404567 2404566 2404565 2404564 2404563 2404562 2404561 2404560 2404559 2404552 2404547 2404626 2404625 2404624 2404623 2404620 2404619 2404618 2404617 2404616 2404615 2404614 2404613 2404612 2404611 2404610 2404609 2404608 2404607 2404606 2404605 2404604 2404603 2404601 2404599 2404598 2404602 2404600 2404597 2404596 2404595 2404594 2404592 2404591 2404590 2404589 2404588 2404587 2404586 2404584 2404582 2404581 2404580 2404757 2404691 2404686 2404685 2404679 2404678 2404674 2404673 2404672 2404665 2404657 2404655 2404653 2404649 2404647 2404688 2404681 2404727 2404722 2404719 2404710 2404708 2404699 2404643 2404642 2404641 2404640 2404638 2404637 2404636 2404635 2404634 2404633 2404631 2404628 2404621 2404746 2404742 2404741 2404732 2404729 2404723 2404713 2404712 2404709 2404705 2404704 2404703 2404702 2404701 2404700 2404698 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• FEI Number: 2429304
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: Cynthia Ow; 647-9993203
• Manufacturer Reason for Recall: It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 9/20/24 was sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Examine your inventory and identify the above-listed device with the affected serial number. 3. Beginning October 28, 2024, please call Olympus Customer Service at 1-800-848-9024, option 3, to request a CCD Color Adjustment . Olympus will arrange for the return of your device to our Olympus Repair Center at a mutually convenient time. Olympus Repair will perform a color adjustment. 4. If you have further distributed this product, identify your customers, and forward them this notification. 5. Olympus requests that you acknowledge receipt of this letter through the Olympus web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number "0454 c. Complete the form as instructed. Olympus requests that you report any complaints, including any imaging issues, to the Olympus Technical Assistance Center (TAC) at 1- 800-848-9024 (option 1), and the FDA. Adverse events experienced with the use ofthis product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by email at Cynthia.Ow@Olympus.com.
• Quantity in Commerce: 1407 units
• 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 = FET