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DeVilbiss, 525 5-liter Oxygen Concentrator recallZ-0724-2023 · DeVilbiss Healthcare LLC · initiated Nov 18, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DeVilbiss Healthcare LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Labeling False and Misleading

What the company is doing

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.

Recall details

Recall number
Z-0724-2023
Status
Open, Classified
Initiated by the company
Nov 18, 2022
Posted by the FDA
Dec 19, 2022
Recalling firm
DeVilbiss Healthcare LLC
Quantity
1004315 (US); 414559 (OUS)
Product code
CAW
FDA submissions
K071397
Distribution
US Nationwide. Foreign distribution pending.

Product description

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

Code information (models, lots, serial numbers)

Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

6 devices cleared under K071397 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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