Olympus Corporation of the Americas: Colonoscope, Model Number PCF-H190DL.

Hazard

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

Details from the source

Reason for recall: Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads. Distribution: US Nationwide distribution. Quantity: 47 Lot/code info: Model Number: PCF-H190DL; UDI DI: 04953170363672; Serial Number: 2046148, 2046377, 2500549, 2501714, 2602501, 2602549, 2602675, 2602884, 2603086, 2605185, 2605189, 2605279, 2605338, 2605343, 2615621, 2716237, 2716306, 2716379, 2727123, 2727529, 2737897, 2738603, 2839269, 2839284, 2839580, 2840038, 2840130, 2840639, 2840669, 2840719, 2840798, 2840928, 2842302, 2942674, 2942814, 2943131, 2943193, 2943240, 2943296, 2943451, 2943708, 2943820, 2944426, 2944690, 2944765, 2944939, 2945260;

UPC codes

04953170363672

Source

Official record: FDA (Device enforcement) ↗

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