DeVilbiss Healthcare recalls 1025 Series oxygen concentrators (models 1025DS, 1025UK, 1025KS, 1025KS-AR) due to updated instruction manual aligning with IEC-60101-1 standards. No action needed for safety.
The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
DeVilbiss Healthcare is recalling its 1025 Series oxygen concentrators to update the instruction manual to meet new safety labeling standards. This recall does not involve a safety hazard or require action from users.
The recall involves updating the instruction manual to comply with IEC-60101-1 safety labeling standards. This is a labeling update, not a safety hazard.
Oxygen concentrator users with the listed model numbers and serial ranges are affected. Patients using medical oxygen therapy are most at risk if they rely on outdated instructions.
Check for model numbers 1025DS, 1025UK, 1025KS, or 1025KS-AR on the device. Serial numbers fall within the specific ranges listed in the recall notice.
DeVilbiss Healthcare will provide an updated instruction manual that meets IEC-60101-1 labeling requirements.
No action is needed. This recall is for updating the instruction manual, not a safety hazard.
The recall does not require discarding or returning the device. The updated manual will be provided by DeVilbiss Healthcare.
No. This is a labeling update to meet safety standards; there is no hazard.
We’ve drafted a message you can send DeVilbiss Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1558-2023 — DeVilbiss Healthcare DeVilbiss Healthcare Hello, I own a DeVilbiss Healthcare that is covered by recall Z-1558-2023 from DeVilbiss Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
