Fresenius Medical Care recalls 2008T and 2008TBluestar hemodialysis machines with CDX software versions 2.72 or earlier that may show false 'Remove USB 2 Device' alerts due to electromagnetic interference.
(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device".
Fresenius Medical Care is recalling specific 2008T and 2008TBluestar hemodialysis machines that have software versions 2.72 or earlier. These machines may show false 'Remove USB 2 Device' alerts when exposed to electromagnetic interference, which could disrupt dialysis treatment.
The machines' UI-MICs board is sensitive to electromagnetic interference (EMI), which can trigger false 'Remove USB 2 Device' alerts. This may cause temporary interruptions in dialysis treatment but does not cause physical harm.
Healthcare facilities using 2008T or 2008TBluestar hemodialysis machines with CDX software versions 2.72 or earlier are affected. Patients receiving dialysis in these facilities are at risk if the false alerts cause treatment interruptions.
Check for model numbers 190713, 190766, 191124, or 191126 on the machine. The software version should be 2.72 or earlier. The recall applies to machines sold with CDX-Indicated for acute and chronic dialysis therapy.
Verify the software version on the machine; if it is 2.72 or earlier, it is affected.
The UI-MICs board in these machines is sensitive to electromagnetic interference, causing false 'Remove USB 2 Device' alerts.
No, the recall does not require stopping use; the false alerts are temporary and do not cause physical harm.
Check the model number on the machine (190713, 190766, 191124, or 191126) and ensure the software version is 2.72 or earlier.
We’ve drafted a message you can send Fresenius Medical Care to request your refund or repair — edit it as you like.
Subject: Recall Z-0734-2023 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-0734-2023 from Fresenius Medical Care. 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.
