DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
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.
US Nationwide. Foreign distribution pending.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0724-2023