Aizu Olympus Co., Ltd.: Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H1

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: 1123 units Lot/code info: Model Number (UDI-DI): BF-1T150 (04953170308185), BF-1T60 (04953170308161), BF-1TH190 (04953170335181), BF-1TQ170 (04953170342943), BF-3C160 (04953170340031), BF-3C40 (04953170308130), BF-H190 (04953170335174), BF-MP190F (04953170395581), BF-MP60 (04953170308277), BF-P150 (04953170308178), BF-P190 (04953170342110), BF-P60 (04953170308123), BF-Q170 (04953170342912), BF-Q190 (04953170335198), BF-XP190 (04953170342134), BF-XP60 (04953170308154), BF-XT160 (04953170340147), BF-XT190 (04953170402470).

UPC codes

04953170308185, 04953170308161, 04953170335181, 04953170342943, 04953170340031, 04953170308130, 04953170335174, 04953170395581, 04953170308277, 04953170308178, 04953170342110, 04953170308123, 04953170342912, 04953170335198, 04953170342134, 04953170308154, 04953170340147, 04953170402470

Source

Official record: FDA (Device enforcement) ↗

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