Recall Z-1721-2025— Getinge Disinfection Ab
Class II · Ongoing
Class II FDA medical device recall by Getinge Disinfection Ab, initiated 2025-04-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Washer Disinfector Aquadis 56; Model Number: 56M. Reason: 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..
- Recalling firm
- Getinge Disinfection Ab
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-02
- Firm location
- Vaxjo, N/A, Sweden
Product description
Washer Disinfector Aquadis 56; Model Number: 56M
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.