Skip to content

Getinge Aquadis 56 recallZ-1720-2025 · Getinge Disinfection Ab · initiated Apr 2, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Getinge Disinfection Ab or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-1720-2025
Status
Open, Classified
Initiated by the company
Apr 2, 2025
Posted by the FDA
May 5, 2025
Recalling firm
Getinge Disinfection Ab
Quantity
102 units (8 US, 94 OUS)
Product code
MEC
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 description

Washer Disinfector Aquadis 56; Model Number: 56A

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 96644).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page