Aizu Olympus Co., Ltd. recalls Transnasal esophagovideoscope-For endoscopy and endoscopic s
Recalled Product
Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.
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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