Aizu Olympus Co., Ltd.: Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T16

Hazard

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

Details from the source

Reason for recall: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection Distribution: Worldwide - US Nationwide distribution. Quantity: 3627 units Lot/code info: Model Numbers: GIF-1TH190 (04953170343360), GIF-1TQ160 (Not recorded), GIF-2T160 (04953170307492), GIF-2TH180 (04953170339745), GIF-H170 (04953170334115), GIF-H180 (04953170339769), GIF-H180J (04953170307539), GIF-H190 (04953170305290), GIF-HQ190 (04953170305276), GIF-LV1 (04953170312373), GIF-N180 (04953170307508), GIF-Q150 (04953170307485), GIF-Q160Z (04953170066795), GIF-Q180 (04953170307522), GIF-XP180N (04953170307515), GIF-XP190N (04953170305313), GIF-XTQ160 (04953170339837).

UPC codes

04953170343360, 04953170307492, 04953170339745, 04953170334115, 04953170339769, 04953170307539, 04953170305290, 04953170305276, 04953170312373, 04953170307508, 04953170307485, 04953170066795, 04953170307522, 04953170307515, 04953170305313, 04953170339837

Source

Official record: FDA (Device enforcement) ↗

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