Aizu Olympus Co., Ltd.: Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.

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: 1243 units Lot/code info: Model Number (UDI-DI): CYF-5 (04953170292323), CYF-VH (04953170411250), CYF-VHR (04953170411298).

UPC codes

04953170292323, 04953170411250, 04953170411298

Source

Official record: FDA (Device enforcement) ↗

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