DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
FDA device recall Z-1558-2023 · posted 2023-05-04 · Open, Classified
Recall details
- Recalling firm
- DeVilbiss Healthcare LLC
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- CAW
- Quantity affected
- 143,397 units
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2023-03-09
- Date posted
- 2023-05-04
- Location
- Somerset, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES (K071397) | Sunrise Medical | 2007-10-01 |