Aizu Olympus Co., Ltd.: Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duodenum, and small intestine) by oral inse

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: 32 units Lot/code info: Model Number (UDI-DI): SIF-Q180 (04953170339936)

UPC codes

04953170339936

Source

Official record: FDA (Device enforcement) ↗

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