Getinge Washer Disinfector models recalled for inadequate installation documentation
Getinge USA is recalling 127 Washer Disinfector models worldwide due to inadequate documentation verifying proper installation. The issue could lead to installation failures and potentially hazardous situations.
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 for inadequate installation documentation and verification. No injuries or illnesses have been reported, and the potential harm is based on theoretical installation failure scenarios rather than documented harm.
Plain-English summary
Getinge Usa Sales Inc is recalling 127 of its Washer Disinfector models (9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW). These devices have been distributed to healthcare facilities worldwide, including 37 U.S. states and countries across Europe, Asia, and the Middle East.
The recall addresses inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This documentation deficiency can lead to installation failure modes and potentially hazardous situations in healthcare settings.
Healthcare facilities with affected devices should contact Getinge Usa Sales Inc or refer to the FDA recall notice for information about installation verification requirements and any necessary corrective actions.
The recalled product
- Product
- Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
- Manufacturer
- Getinge Usa Sales Inc
- Affected units
- 127
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)
- UDI Codes: [07340153710023
- 07340153710047
- 07340153710054
- 07340153710061
- 9122EW 07340153710030
- 07340153710078.] Serial Numbers: WAA088008
- WAA088276
- WAA089054
- WAA089188
- WAA089511
- WAA091312
- WAA092134
- WAA097871
- WAA098978
- WAA087395
- WAA087675
- WAA087676
- WAA088563
- WAA088677
- WAA088684
Distribution
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