FDA-Device2022-12-28Class II
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
DeVilbiss Healthcare LLC
Hazard
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.
Sold states
US Nationwide. Foreign distribution pending.
Affected count
1004315 (US); 414559 (OUS)
Manufactured in
100 Devilbiss Dr, Somerset, PA, United States
Products
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0724-2023Don't want to check this manually?
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