DeVilbiss 525 Oxygen Concentrator Recalled Due to Excessive Heat
DeVilbiss is recalling the 525 oxygen concentrator because the device can become excessively hot, with external parts potentially exceeding 105.8 degrees Fahrenheit. The firm has updated the user manual to include additional safety warnings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with a thermal hazard that could cause burns. No injuries or illnesses have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported warrant a High severity score.
Plain-English summary
DeVilbiss Healthcare LLC is recalling the Model 525DS and 525DS-Q versions of its 525 5-liter Oxygen Concentrator. Approximately 1,004,315 units were distributed nationwide in the United States, with 414,559 units distributed internationally.
The firm has received complaints of the device becoming hot. Applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit).
In response, the firm has updated the user manual to include warnings about potential heat exposure, clarification on expected service life, and guidance on required maintenance to certain components. Consumers using this device should review the updated manual for safety information and maintenance instructions.
The recalled product
- Product
- DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
- Manufacturer
- DeVilbiss Healthcare LLC
- Hazard
Distribution
Distributed nationwide across the United States.
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