FDA Device recall Z-0181-2025
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
- FDA Device
- Class II
- ongoing
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class II recall of Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100 by Olympus, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0181-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-21 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
Product
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
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.
Identifiers
| code_info | UDI-DI: 04953170420191; Serial Numbes: 2304049 2404551 2404550 2404541 2404537 2404577 2404576 2404574 2404571 2404570…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 2404683 2404680 2404675 2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0181-2025%22
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