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Class 2 Device Recall 1025 SERIES OXYGEN CONCENTRATOR |
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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
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Product Classification |
Generator, oxygen, portable - Product Code CAW
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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
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For Additional Information Contact |
Roberto Munoz 989-989-5190
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = CAW and Original Applicant = SUNRISE MEDICAL
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