Aizu Olympus Co., Ltd.: Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T1

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: 3344 units 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).

UPC codes

04953170307645, 04953170307652, 04953170334184, 04953170334160, 04953170339585, 04953170339608, 04953170339639, 04953170339653, 04953170305177, 04953170305153, 04953170305139, 04953170305115, 04953170312410, 04953170312397, 04953170307621, 04953170307638, 04953170307669, 04953170307690, 04953170307706

Source

Official record: FDA (Device enforcement) ↗

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