Recall Z-0724-2023 ยท CAW Generator, Oxygen, Portable
DeVilbiss Healthcare LLC
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
| Date | Dec 19, 2022 (initiated Nov 18, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling False and Misleading |
| Action | 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 expec |
| Quantity | 1004315 (US); 414559 (OUS) |
| Distribution | US Nationwide. Foreign distribution pending. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071397 | DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES Sunrise Medical, Oct 1, 2007 |