DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Recall
- Recall Number
- Z-0724-2023
- Event Number
- 91112
- Firm
- DeVilbiss Healthcare LLC
- FEI Number
- 2515872
- Product Code
- CAW
- Status
- Open, Classified
- Root Cause
- Labeling False and Misleading
- Initiated
- November 18, 2022
- Posted
- December 19, 2022
- Address
- 100 Devilbiss Dr, Somerset, PA, 15501-2125
Description
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
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.
On November 18, 2022, the firm notified customers through Urgent Notice Medical Device Correction letters/emails. The firm is updating its instruction manual to include the following: " warnings related to applied parts that may come into contact with a patient that, when under single fault failure conditions while operating at maximum environmental temperatures, could cause the surface temperature of the part to exceed 41C; " clarifications regarding the expected service life for the unit; and " additional instructions regarding wear components that may require maintenance during the expected service life of the product. Customers may navigate to www.recallrtr.com/525series to obtain copies of the updated instruction manual. The firm may be reached at 1 (833) 408-0512, from 8:00 am to 7:00 pm EST Monday through Friday.
US Nationwide. Foreign distribution pending.
1004315 (US); 414559 (OUS)