Aizu Olympus Co., Ltd.: Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.

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: 16 units Lot/code info: Model Number (UDI-DI): HYF-XP (04953170340178).

UPC codes

04953170340178

Source

Official record: FDA (Device enforcement) ↗

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