FDA (Devices) recall action 96644
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.
The agency’s own wording, quoted from the enforcement report.
Getinge Disinfection Ab recalls the Washer Disinfector Aquadis 56 (Model 56M) because the frequency inverter is not programmed to specification, causing the circulation pump to start earlier than expected and wear the axial seal prematurely.
Getinge Disinfection Ab is recalling Washer Disinfector Aquadis 56 (Model 56A) units due to a frequency inverter programming error that causes the circulation pump to start earlier than expected, leading to accelerated wear on the axial seal.