Colonovideoscope Model CF-H180AL
Check against the official notice below — it lists the full affected range.
Olympus Corporation of the Americas has recalled one unit of the CF-H180AL colonovideoscope due to an incorrect camera unit (CCD) that may have been installed during manufacturing. This defective unit has a narrower viewing angle than normal and may cause EndoTherapy devices to protrude approximately 1.4 mm further than intended during use.
The affected unit (serial number 2501131, UDI-DI: 04953170339615) was distributed nationwide in Kentucky and poses a risk of patient injury, including mucosal damage that could result in hemorrhage or bleeding. The recall source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding
Reason for recall: A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding Distribution: US Nationwide distribution in the state of KY. Quantity: 1 unit Lot/code info: UDI-DI: 04953170339615 Serial number: 2501131
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.