FDANovember 18, 2022device
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
devilbiss healthcaredevilbiss
UPCs
0088530400084600885304009689
Recall history
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