PlainRecordsFDA · Medical device recall
Washer Disinfector Aquadis 56… and 1 more product
- 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.
- Status
- Ongoing
- 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…
- Enforcement report date
- May 14, 2025
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Getinge Disinfection Ab
- 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.
- 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.
What this record is about
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“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.”Washer Disinfector Aquadis 56; Model Number: 56A, FDA enforcement report, 2025-05-14. The caption is the record's own words.
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FDA device name: Disinfector, Medical Devices
2 products in this recall
Washer Disinfector Aquadis 56…
- Product
- Washer Disinfector Aquadis 56; Model Number: 56A
- Quantity
- 102 units (8 US, 94 OUS)
- Codes and lots
- 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.
- Recall started
- April 2, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Disinfector, Medical Devices
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- 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 recallresponses.qrc@getinge.com. 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
- Recall number
- Z-1720-2025
Washer Disinfector Aquadis 56…
- Product
- Washer Disinfector Aquadis 56; Model Number: 56M
- Quantity
- 424 units (79 US, 345 OUS)
- 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.
- Recall started
- April 2, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Disinfector, Medical Devices
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- 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 recallresponses.qrc@getinge.com. 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
- Recall number
- Z-1721-2025
This recall among the others
- FDA's enforcement report came 42 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement reports, recall numbers Z-1720-2025, Z-1721-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1720-2025, May 14, 2025. "Washer Disinfector Aquadis 56… and 1 more product." PlainRecords, https://plainrecords.com/recall/device/z-1720-2025/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections