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DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model… recallZ-1558-2023 · DeVilbiss Healthcare LLC · initiated Mar 9, 2023

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 instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.

FDA root cause category: Labeling design

What the company is doing

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.

Recall details

Recall number
Z-1558-2023
Status
Open, Classified
Initiated by the company
Mar 9, 2023
Posted by the FDA
May 4, 2023
Recalling firm
DeVilbiss Healthcare LLC
Quantity
143,397 units
Product code
CAW
FDA submissions
K071397
Distribution
Worldwide - US Nationwide distribution.

Product description

DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR

Code information (models, lots, serial numbers)

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

Devices named in this recall

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

Other devices under the same FDA submission

5 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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