Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

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.

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 [email protected].