Aizu Olympus Co., Ltd. recalls Small intestinal videoscope-For endoscopy and endoscopic sur
Recalled Product
Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duodenum, and small intestine) by oral insertion or the lower digestive tract (including the anus, rectum, sigmoid colon, colon, ileocecal valve, and small intestine) by anal insertion. - Model Number: SIF-Q180.
Hazard / Issue
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
Issued by
FDA
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