DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Summary
The FDA issued a Class II for DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025 by DeVilbiss Healthcare LLC. Reason: 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
Source
Device Recall
External ID
Z-1558-2023
Action Date
2023-05-10
Status
Ongoing
Category
device
Product Description
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Lot/Code Info: 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
Quantity Affected: 143,397 units
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.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-09
Company
Somerset, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DeVilbiss Healthcare LLC has 5 FDA actions in our database, including 3 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DeVilbiss Healthcare LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DeVilbiss Healthcare LLC have FDA actions?
DeVilbiss Healthcare LLC has 5 FDA actions in our database, including 3 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1558-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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