Washer Disinfector Aquadis 56 Model 56A pump seal defect recall
Getinge Disinfection Ab is recalling Washer Disinfector Aquadis 56 (Model 56A) units due to a frequency inverter programming error that causes the circulation pump to start earlier than expected, leading to accelerated wear on the axial seal.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text does not report any illnesses, injuries, or device failures—only a design/programming defect that causes accelerated component wear. This is a precautionary recall based on a theoretical risk, meeting the Moderate (score 2) threshold.
Plain-English summary
Getinge Disinfection Ab is recalling the Washer Disinfector Aquadis 56, Model 56A. The frequency inverter in these units is not programmed according to manufacturer specification, which causes the circulation pump to start earlier than expected.
This premature pump activation results in additional and accelerated wear and tear on the axial seal in the pump housing, potentially compromising the device's function. A total of 102 units have been distributed worldwide, including 8 units in the United States.
Facilities that have received this equipment should contact Getinge Disinfection Ab for further guidance. The recall affects devices with Model 56A and UDI-DI 07340153710344. Consult the manufacturer or the FDA for instructions on device inspection, repair, or replacement.
The recalled product
- Product
- Washer Disinfector Aquadis 56; Model Number: 56A
- Manufacturer
- Getinge Disinfection Ab
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Getinge Disinfection Ab under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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