Recall Z-0724-2023— DeVilbiss Healthcare LLC

Name: FDA recall Z-0724-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-18

Class II · Ongoing

Class II FDA medical device recall by DeVilbiss Healthcare LLC, initiated 2022-11-18. It names one FDA 510(k) clearance: K071397. Product: DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q. 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..

Recalling firm: DeVilbiss Healthcare LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-11-18
Firm location: Somerset, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K071397 — DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIESSunrise Medical·cleared 2007-10-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.