Medical device recalls Moderate risk

Getinge Disinfection Ab recalls Washer Disinfector Aquadis 56; Model Number: 56A

Recall date
April 2, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1720-2025
FDA classification
Class II
Brand / firm
Getinge Disinfection Ab
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Brazil, Canada, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Washer Disinfector Aquadis 56; Model Number: 56A

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