DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
FDA device recall Z-0724-2023 · posted 2022-12-19 · Open, Classified
Recall details
- Recalling firm
- DeVilbiss Healthcare LLC
- 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.
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Open, Classified
- Product code
- CAW
- Quantity affected
- 1004315 (US); 414559 (OUS)
- Distribution
- US Nationwide. Foreign distribution pending.
- Date initiated
- 2022-11-18
- Date posted
- 2022-12-19
- Location
- Somerset, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES (K071397) | Sunrise Medical | 2007-10-01 |