FDA Enforcement Class II Ongoing

Washer Disinfector Aquadis 56; Model Number: 56M

Recall: Z-1721-2025 · Reported May 14, 2025

Enforcement

Recall Number
Z-1721-2025
Event ID
96644
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Getinge Disinfection Ab
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
May 14, 2025
Initiation Date
April 2, 2025
Classification Date
May 5, 2025
Address
Ljungadalsgatan 11, N/A, Vaxjo, N/A, N/A, Sweden

Description

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.

Code Info

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

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.

Quantity

424 units (79 US, 345 OUS)