DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
FDA Recall Z-0724-2023 · Posted 2022-12-19
Advertisement
Recalling FirmDeVilbiss Healthcare LLC
Recall StatusOpen, Classified
Product CodeCAW
Date Initiated2022-11-18
Product Quantity1004315 (US); 414559 (OUS)
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.
Firm 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 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
Distribution Pattern
US Nationwide. Foreign distribution pending.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement