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U.S. Department of Health and Human Services

Class 2 Device Recall 1025 SERIES OXYGEN CONCENTRATOR

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  Class 2 Device Recall 1025 SERIES OXYGEN CONCENTRATOR see related information
Date Initiated by Firm March 09, 2023
Date Posted May 04, 2023
Recall Status1 Open3, Classified
Recall Number Z-1558-2023
Recall Event ID 91804
510(K)Number K071397  
Product Classification Generator, oxygen, portable - Product Code CAW
Product DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Code Information Model 1025DS - UDI-DI: 00885304000846; Serial Numbers A175230001DS to A232160185DS; Model 1025UK - UDI-DI: 00885304022480; Serial Numbers A179210001US to A232060432US; Model 1025KS - UDI-DI: 00853040224734; Serial Numbers A176060001KS to A232220085KS; Model 1025KS-AR - UDI-DI: 00853040224734; Serial Numbers A216240003KS to A229210010KR
Recalling Firm/
Manufacturer		 DeVilbiss Healthcare LLC
100 Devilbiss Dr
Somerset PA 15501-2125
For Additional Information Contact Roberto Munoz
989-989-5190
Manufacturer Reason
for Recall		 The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
FDA Determined
Cause 2		 Labeling design
Action An URGENT NOTICE MEDICAL DEVICE CORRECTION notification dated 3/9/23 was sent to customers. Actions to be Taken by Our Customers Please immediately click on the hyperlinked Verification Code at the top of this Notice to go to our dedicated instruction manual update website, www.recallrtr.com/1025series (or access the website manually), and follow the simple process set up to: ¿ Download electronic copies, or order hard copies, of the updated instruction manual. ¿ Download a spreadsheet containing the serial numbers of all affected units sold to your company. ¿ Replace the instruction manual for any units in your possession, and distribute the updated instruction manual to your customers, and ¿ Submit an Acknowledgement Form confirming the number of instruction manuals you replaced and distributed to customers to replace. Should you need further assistance, we have also set up a dedicated call center, which can be reached at 1 (833) 820-0836, from 8:00 am to 7:00 pm EST Monday through Friday.
Quantity in Commerce 143,397 units
Distribution Worldwide - US Nationwide distribution.
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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