DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
FDA Recall Z-1558-2023 · Posted 2023-05-04
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Recalling FirmDeVilbiss Healthcare LLC
Recall StatusOpen, Classified
Product CodeCAW
Date Initiated2023-03-09
Product Quantity143,397 units
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.
Firm 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.
Root Cause
Labeling design
Distribution Pattern
Worldwide - US Nationwide distribution.
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.
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