DeVilbiss Healthcare 1025 Series Oxygen Concentrator Instruction Manual Update
DeVilbiss Healthcare is updating the instruction manual for its 1025 Series Oxygen Concentrator to comply with IEC-60101-1 standard labeling requirements. This recall affects 143,397 units distributed nationwide and worldwide.
What this means for you
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: FDA Class II recall addressing a documentation and labeling deficiency. No illnesses, injuries, or explicit safety hazards are documented in the source. The manual update is required to align with IEC-60101-1 standard requirements, but no patient harm has been reported.
Plain-English summary
DeVilbiss Healthcare LLC is recalling four models of the 1025 Series Oxygen Concentrator: model numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR. The instruction manual is being replaced with an updated version to align with labeling requirements specified in the IEC-60101-1 standard.
This recall affects 143,397 units that have been distributed nationwide and worldwide. Specific affected serial number ranges are provided for each model variant.
Consumers with an affected device should contact DeVilbiss Healthcare LLC to obtain the updated instruction manual.
The recalled product
- Product
- DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
- Manufacturer
- DeVilbiss Healthcare LLC
- Hazard
- labeling-deficiency
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 (8)
- Model 1025DS - UDI-DI: 00885304000846
- Serial Numbers A175230001DS to A232160185DS
- Model 1025UK - UDI-DI: 00885304022480
- Serial Numbers A179210001US to A232060432US
- Model 1025KS - UDI-DI: 00853040224734
- Serial Numbers A176060001KS to A232220085KS
- Model 1025KS-AR - UDI-DI: 00853040224734
- Serial Numbers A216240003KS to A229210010KR
Distribution
Distributed nationwide across the United States.
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