Olympus Corporation of the Americas: Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

Hazard

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.

Details from the source

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. Distribution: US Nationwide distribution. Quantity: 1407 units Lot/code info: 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 2404728 2404726 2404725 2404724 2404721 2404720 2404718 2404716 2404715 2404714 2404711 2404707 2404697 2404694 2404693 2404692 2404690 2404689 2404684 2404677 2404660 2404656 2404644 2404717 2404706 2404817 2404816 2404812 2404805 2404804 2404803 2404801 2404800 2404798 2404796 2404795 2404794 2404790 2404788 2404797 2404793 2404787 2404785 2404781 2404780 2404775 2404774 2404773 2404772 2404771 2404769 2404767 2404765 2404761 2404792 2404791 2404789 2404786 2404784 2404783 2404782 2404779 24047

UPC codes

04953170420191

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.