OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories
Check against the official notice below — it lists the full affected range.
Olympus Corporation of the Americas is recalling the OER-Elite Endoscope Reprocessor, a device used to clean and disinfect flexible endoscopes and their accessories. The detergent and alcohol tank tubing may have been incorrectly assembled in some units, causing alcohol to be dispensed during the detergent cycle and detergent to be dispensed during the alcohol cycle. This incorrect dispensing can result in ineffective endoscope reprocessing and expose patients to residual detergent. The recall affects 295 units distributed nationwide across all serial numbers.
The recall notice does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent
Reason for recall: The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent Distribution: Nationwide Quantity: 295 units Lot/code info: All serial numbers. UDI: 04953170404047
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.