DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Summary
The FDA issued a Class II for DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q by DeVilbiss Healthcare LLC. Reason: The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact wi.
Details
Source
Device Recall
External ID
Z-0724-2023
Action Date
2022-12-28
Status
Ongoing
Category
device
Product Description
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Lot/Code Info: Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots
Quantity Affected: 1004315 (US); 414559 (OUS)
Reason for Recall
The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.
Distribution
US Nationwide. Foreign distribution pending.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-18
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 404 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-0724-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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