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DeVilbiss Healthcare LLC recalls DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Recalled December 28, 2022 · FDA recall Z-0724-2023 · DeVilbiss Healthcare
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. · FDA Class II
Units
1004315 (US); 414559 (OUS)
Sold at
US Nationwide. Foreign distribution pending.
Description
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.
Product
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Manufacturer(s)
DeVilbiss Healthcare LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →