Recall Z-0181-2025 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Olympus Corporation of the Americas
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
| Date | Oct 23, 2024 (initiated Aug 21, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 |
| Quantity | 1407 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222584 | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS Olympus Medical Systems Corporation, Apr 26, 2023 |