DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Reported: December 28, 2022 Initiated: November 18, 2022 #Z-0724-2023
Product Description
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Reason for Recall
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.
Details
- Recalling Firm
- DeVilbiss Healthcare LLC
- Units Affected
- 1004315 (US); 414559 (OUS)
- Distribution
- US Nationwide. Foreign distribution pending.
- Location
- Somerset, PA
Frequently Asked Questions
What product was recalled? ▼
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q. Recalled by DeVilbiss Healthcare LLC. Units affected: 1004315 (US); 414559 (OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2022. Severity: Moderate. Recall number: Z-0724-2023.
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