Recall Z-1558-2023 ยท CAW Generator, Oxygen, Portable
DeVilbiss Healthcare LLC
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
| Date | May 4, 2023 (initiated Mar 9, 2023) |
| Status | Open, Classified |
| Reason | The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard. |
| Root cause | 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 |
| Quantity | 143,397 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071397 | DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES Sunrise Medical, Oct 1, 2007 |