Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery Model Numbers: TJF-145, TJF-150, TJF-Q180V, TJF-Q190V.

Reason: 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

Code information: Model Number (UDI-DI): TJF-145 (04953170339950), TJF-150 (04953170307553), TJF-Q180V (04953170229503), TJF-Q190V (04953170405563).

Distribution pattern: Worldwide - US Nationwide distribution.