Summary
The FDA issued a Class II for Washer Disinfector Aquadis 56; Model Number: 56A 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, resu.
Details
Source
Device Recall
External ID
Z-1720-2025
Action Date
2025-05-14
Status
Ongoing
Category
device
Product Description
Washer Disinfector Aquadis 56; Model Number: 56A
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.
Quantity Affected: 102 units (8 US, 94 OUS)
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, 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-02
Company
Vaxjo, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 146 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Getinge Disinfection Ab has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Getinge Disinfection Ab) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Getinge Disinfection Ab have FDA actions?
Getinge Disinfection Ab has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1720-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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