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FDA (Device enforcement)Recalled 2025-04-02class ii

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

Hazard

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.

Details from the source

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. Distribution: 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, Iraq, Italy, Japan, Kenya, Korea, Kuwait, Latvia, Lithuania, Malaysia, Mauritania, Mexico, Netherland Quantity: 102 units (8 US, 94 OUS) Lot/code info: Model: 56A; UDI-DI: 07340153710344; Serial Numbers: WAA104857, WAA107934, WAA107937, WAA108359, WAA108540, WAA108963, WAA109338, WAA110115, WAA108201, WAA109175, WAA109884, WAA109989, WAA109998, WAA110804, WAA600035, WAA109641, WAA109651, WAA111118, WAA106820, WAA106835, WAA106841, WAA107693, WAA107428, WAA107429, WAA600055, WAA600060, WAA600061, WAA106607, WAA106668, WAA106753, WAA107358, WAA109804, WAA106793, WAA108419, WAA110679, WAA109022, WAA109030, WAA109564, WAA109566, WAA109595, WAA109598, WAA105283, WAA107346, WAA600188, WAA107314, WAA107330, WAA110062, WAA110075, WAA110084, WAA110104, WAA110163, WAA110302, WAA110201, WAA600558, WAA110953, WAA110963, WAA110138, WAA109975, WAA107281, WAA107303, WAA108972, WAA110228, WAA110162, WAA110727, WAA110738, WAA110742, WAA110803, WAA108669, WAA108670, WAA108673, WAA108722, WAA110762, WAA110631, WAA110636, WAA600167, WAA600168, WAA110482, WAA111159, WAA111170, WAA111183, WAA105284, WAA108615, WAA109514, WAA110174, WAA110178, WAA110898, WAA110907, WAA600077, WAA600177, WAA600338, WAA600339, WAA600340, WAA600341, WAA600342, WAA600343, WAA600344, WAA600394, WAA600705, WAA600706, WAA600711, WAA600712, WAA600713.

UPC codes

07340153710344

Source

Official record: FDA (Device enforcement)

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

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