FDA Enforcement
Class II
Ongoing
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Recall: Z-0724-2023
·
Reported December 28, 2022
Enforcement
- Recall Number
- Z-0724-2023
- Event ID
- 91112
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- DeVilbiss Healthcare LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- December 28, 2022
- Initiation Date
- November 18, 2022
- Classification Date
- December 19, 2022
- Address
- 100 Devilbiss Dr, Somerset, PA, 15501-2125, United States
Description
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Reason
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.
Code Info
Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots
Distribution
US Nationwide. Foreign distribution pending.
Quantity
1004315 (US); 414559 (OUS)