Recall Z-0724-2023
DeVilbiss Healthcare LLC · initiated November 18, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Codes / lots: Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots
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.
FDA-determined cause: Labeling False and Misleading
Action taken
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.
Details
- Recall number
- Z-0724-2023
- Initiated
- November 18, 2022
- Posted by FDA
- December 19, 2022
- Product code
- CAW – Generator, Oxygen, Portable
- Quantity
- 1004315 (US); 414559 (OUS)
- Distribution
- US Nationwide. Foreign distribution pending.
- Recalling firm
- DeVilbiss Healthcare LLC, Somerset, PA