DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Reported: May 10, 2023 Initiated: March 9, 2023 #Z-1558-2023
Product Description
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Reason for Recall
The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
Details
- Recalling Firm
- DeVilbiss Healthcare LLC
- Units Affected
- 143,397 units
- Distribution
- Worldwide - US Nationwide distribution.
- Location
- Somerset, PA
Frequently Asked Questions
What product was recalled? ▼
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR. Recalled by DeVilbiss Healthcare LLC. Units affected: 143,397 units.
Why was this product recalled? ▼
The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 10, 2023. Severity: Moderate. Recall number: Z-1558-2023.
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