DeVilbiss Healthcare LLC Recall 91112
Description: DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
DeVilbiss Healthcare LLC Recall 91112 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0724-2023 |
| Event ID | 91112 |
| Event Description | DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q |
| Product Type | Devices |
| Distribution | US Nationwide. Foreign distribution pending. |
| Quantity | 1004315 (US); 414559 (OUS) |
| Recall 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. |
| Device Classification | 20221228 |
| Device Code Info | Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots |
| Center Classification Date | 20221219 |
| Recall Initiation Date | 20221118 |
| Recalling Firm | DeVilbiss Healthcare LLC |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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