Aizu Olympus Co., Ltd. recalls Hysteroscope-For endoscopic diagnosis within the uterus Mod
Recalled Product
Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
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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