medical Class II Updated 2023-11-29

Aizu Olympus Co., Ltd. recalls Colonoscope: for endoscopy and endoscopic surgery within the

Recalled Product

Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.

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): CF-2T160I (04953170307645), CF-2T160L (04953170307652), CF-H170I (04953170334184), CF-H170L (04953170334160), CF-H180AI (04953170339585), CF-H180AL (04953170339608), CF-H180DI (04953170339639), CF-H180DL (04953170339653), CF-H190I (04953170305177), CF-H190L (04953170305153), CF-HQ190I (04953170305139), CF-HQ190L (04953170305115), CF-LV1I (04953170312410), CF-LV1L (04953170312397), CF-Q150I (04953170307621), CF-Q150L (04953170307638), CF-Q160S (04953170307669), CF-Q180AI (04953170307690), CF-Q180AL (04953170307706).
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