DeVilbiss Healthcare LLC recalls DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q

Recall date

November 18, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0724-2023

FDA classification

Class II

Brand / firm

DeVilbiss Healthcare LLC

Sold / distributed

US Nationwide. Foreign distribution pending.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q