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U.S. Department of Health and Human Services

Class 2 Device Recall DeVilbiss

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  Class 2 Device Recall DeVilbiss see related information
Date Initiated by Firm November 18, 2022
Date Posted December 19, 2022
Recall Status1 Open3, Classified
Recall Number Z-0724-2023
Recall Event ID 91112
510(K)Number K071397  
Product Classification Generator, oxygen, portable - Product Code CAW
Product DeVilbiss, 525 5-liter Oxygen Concentrator
Models 525DS, 525DS-Q
Code Information Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots
Recalling Firm/
Manufacturer		 DeVilbiss Healthcare LLC
100 Devilbiss Dr
Somerset PA 15501-2125
For Additional Information Contact Roberto Munoz
800-338-1988
Manufacturer 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.
FDA Determined
Cause 2		 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 41¿C; " 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.
Quantity in Commerce 1004315 (US); 414559 (OUS)
Distribution US Nationwide. Foreign distribution pending.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CAW and Original Applicant = SUNRISE MEDICAL
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