medical Class II Updated 2023-11-29

Aizu Olympus Co., Ltd. recalls Bronchoscope-for endoscopy and endoscopic surgery within the

Recalled Product

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-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

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

Distribution: Nationwide (United States)

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).

View official government recall

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