Z-1721-2025Class II

Washer Disinfector Aquadis 56; Model Number: 56M

Name: Z-1721-2025 Washer Disinfector Aquadis 56; Model Number: 56M
Creator: Getinge Disinfection Ab
Published: 2025-04-02
License: https://open.fda.gov/license/

Getinge Disinfection AB / initiated 2025-04-02 / Open, Classified / root cause: supplier

FDA source

Getinge Disinfection Ab began a recall of Washer Disinfector Aquadis 56; Model Number: 56M on 2025-04-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1721-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-02
Posted: 2025-05-05
Recalling firm: Getinge Disinfection AB
Product: Washer Disinfector Aquadis 56; Model Number: 56M
Product code: MEC Disinfector, Medical Devices
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.
Root cause tag: supplier
FDA root cause: Under Investigation by firm
Action: On April 2, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Customer Actions 1. Check the serial number of yourWasher Disinfector Aquadis 56 to determine if it is affected. The serial number can be found on the marking label, located on the inside of the front Panel door. 2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. 3. Complete and return the enclosed response form Getinge by e-mailing a copy to [email protected]. Note: If your unit is covered by a service agreement, Getinge will carry out the testing and required rework, if necessary, during the next regularly scheduled maintenance. If your facility currently does not have a service agreement with Getinge, our field service technicians will contact you to set up testing. Getinge will conduct testing to determine if the frequency inverter is programmed or not, and if it is found to be affected by this issue, the memory module in the frequency inverter will be replaced, free of charge. Actions to be taken by Getinge: Getinge will conduct testing to determine if the frequency inverter is programmed or not, and if it is found to be affected by this issue, the memory module in the frequency inverter will be replaced, free of charge. This will be performed during your routine planned maintenance to avoid any inconvenience. Additional Information: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax using the following: - Online: www.accessdata.fda.gov/scripts/medwatch/ - Regular Mail: Download form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form - Fax: 1-800-FDA-0178 (1-800-332-0178) We deeply regret this inconve
Quantity in commerce: 424 units (79 US, 345 OUS)
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1721-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1720-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-05
Z-1721-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-05

Product code MEC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)