Skip to content
Recall Observatory FDA recall evidence

Device product

Washer Disinfector Aquadis 56; Model Number: 56M

Z-1721-2025

April 02, 2025

Class II

Product summary

Firm
Getinge Disinfection Ab
Event
Event 96644
Status
Ongoing
Classification
Class II
Quantity
424 units (79 US, 345 OUS)
Official record key
device-enforcement:Z-1721-2025

Official wording

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.

Code information: Model: 56M; UDI-DI: 07340153710351; Serial Numbers: WAA105199, WAA105251, WAA105268, WAA105357, WAA105535, WAA105700, WAA105915, WAA105972, WAA105973, WAA106079, WAA106114, WAA106135, WAA106451, WAA106471, WAA106487, WAA106505, WAA107436, WAA107492, WAA107565, WAA107581, WAA107588, WAA107920, WAA108225, WAA108807, WAA108920, WAA108921, WAA108922, WAA109036, WAA109047, WAA109231, WAA109377, WAA109392, WAA109635, WAA109687, WAA109731, WAA109790, WAA109835, WAA109840, WAA109853, WAA109907, WAA109972, WAA110109, WAA110366, WAA110487, WAA110546, WAA110557, WAA110711, WAA110726, WAA110802, WAA110847, WAA110862, WAA110984, WAA110999, WAA111007, WAA111011, WAA111068, WAA111086, WAA111087, WAA111200, WAA600033, WAA600054, WAA600100, WAA600102, WAA600103, WAA600145, WAA600190, WAA600282, WAA600369, WAA600431, WAA600434, WAA600444, WAA600445, WAA600553, WAA600554, WAA600587, WAA600588, WAA600609, WAA600610, WAA600704, WAA106987, WAA110250, WAA110257, WAA108634, WAA110823, WAA108206, WAA109799, WAA109066, WAA109076, WAA109091, WAA109373, WAA110528, WAA111028, WAA600134, WAA600189, WAA110820, WAA110123, WAA108871, WAA108872, WAA106724, WAA109403, WAA109405, WAA109495, WAA109933, WAA110513, WAA110527, WAA110617, WAA109658, WAA109672, WAA110029, WAA110779, WAA110893, WAA107614, WAA108608, WAA108610, WAA109222, WAA109764, WAA109782, WAA109946, WAA110055, WAA110083, WAA110204, WAA110801, WAA600066, WAA600068, WAA600072, WAA600507, WAA600508, WAA106520, WAA106618, WAA106639, WAA110594, WAA110595, WAA110842, WAA111150, WAA600105, WAA108702, WAA108040, WAA106692, WAA107486, WAA107491, WAA108832, WAA108998, WAA109241, WAA109244, WAA109885, WAA110167, WAA110279, WAA110290, WAA110303, WAA110349, WAA110394, WAA110406, WAA111093, WAA111098, WAA111112, WAA600216, WAA600441, WAA600509, WAA600560, WAA600611, WAA600612, WAA600613, WAA600648, WAA107279, WAA107940, WAA109140, WAA109973, WAA110534, WAA110545, WAA111142, WAA111174, WAA111177, WAA111185, WAA106240, WAA106760, WAA110566, WAA110876, WAA108501, WAA108502, WAA108514, WAA109093, WAA109409, WAA109805, WAA109808, WAA109966, WAA110032, WAA110037, WAA110618, WAA600141, WAA600220, WAA600221, WAA600222, WAA600223, WAA600253, WAA600254, WAA600255, WAA600450, WAA600451, WAA600585, WAA600586, WAA110881, WAA105641, WAA105682, WAA106980, WAA107125, WAA108151, WAA108367, WAA108394, WAA108519, WAA108531, WAA108953, WAA109653, WAA109874, WAA110018, WAA110027, WAA110056, WAA110327, WAA111114, WAA600106, WAA600186, WAA600187, WAA107148, WAA107232, WAA107267, WAA107307, WAA107360, WAA107418, WAA108067, WAA108136, WAA108137, WAA108161, WAA108170, WAA108217, WAA108409, WAA108479, WAA108499, WAA108500, WAA108653, WAA108743, WAA108745, WAA108746, WAA108863, WAA108864, WAA109187, WAA109199, WAA109200, WAA109207, WAA109269, WAA109278, WAA109285, WAA109305, WAA109309, WAA109314, WAA109327, WAA109497, WAA109501, WAA109507, WAA109565, WAA110208, WAA110226, WAA110361, WAA110643, WAA110836, WAA110845, WAA110937, WAA110938, WAA111012, WAA111032, WAA111055, WAA600047, WAA600053, WAA600135, WAA600256, WAA600286, WAA600287, WAA600288, WAA600370, WAA600371, WAA600436, WAA600438, WAA600442, WAA600446, WAA600448, WAA600555, WAA110297, WAA110315, WAA107182, WAA109948, WAA110950, WAA110268, WAA110648, WAA110663, WAA107190, WAA107199, WAA109370, WAA109513, WAA110486, WAA106247, WAA106399, WAA106412, WAA108983, WAA110013, WAA110420, WAA600217, WAA600649, WAA600858, WAA109765, WAA109696, WAA109713, WAA109737, WAA109182, WAA109673, WAA109686, WAA109862, WAA109864, WAA110256, WAA110274, WAA110460, WAA109949, WAA106546, WAA106548, WAA107084, WAA107905, WAA108894, WAA109343, WAA109352, WAA109393, WAA109908, WAA109931, WAA110686, WAA110833, WAA111083, WAA600218, WAA600219, WAA600278, WAA600556, WAA107522, WAA107594, WAA108973, WAA108975, WAA110638, WAA111052, WAA111053, WAA111186, WAA111189, WAA110395, WAA107136, WAA110323, WAA110338, WAA110360, WAA110370, WAA107215, WAA106992, WAA108059, WAA108623, WAA110703, WAA105696, WAA107624, WAA107641, WAA107691, WAA107699, WAA107731, WAA107736, WAA107746, WAA107756, WAA107763, WAA107788, WAA107790, WAA107801, WAA107804, WAA107806, WAA107825, WAA107829, WAA107858, WAA107860, WAA107883, WAA107897, WAA108226, WAA108264, WAA108267, WAA108300, WAA108301, WAA108410, WAA108466, WAA108952, WAA109249, WAA109260, WAA109261, WAA109266, WAA109340, WAA109688, WAA109757, WAA109937, WAA110374, WAA110428, WAA110432, WAA110452, WAA110453, WAA600011, WAA600082, WAA600101, WAA600104, WAA600107, WAA600129, WAA600130, WAA600285, WAA600551, WAA600552, WAA600559, WAA109920, WAA109929, WAA600280, WAA600281, WAA110756, WAA110757, WAA109631, WAA109916, WAA110235, WAA110248, WAA600289, WAA600327, WAA110154, WAA600650, WAA107607.

Distribution pattern: 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, Netherlands, New Caledonia, Nigeria, Norway, Oman, Pakistan, Philippines, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Vietnam, Zambia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.