Z-0724-2023 Class II Ongoing
FDA device recall Z-0724-2023 was initiated by DeVilbiss Healthcare LLC on November 18, 2022 and is designated Class II. 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 de… The recall status is ongoing. Affected quantity: 1004315 (US); 414559 (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2022
- Initiation Date
- November 18, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1004315 (US); 414559 (OUS)
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.
Distribution Pattern
US Nationwide. Foreign distribution pending.
Code Information
Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots