Fresenius Medical Care recalls Novalung sensor boxes (F30000163) that may show error messages #206 or #208 during use, potentially indicating technical failure in long-term respiratory support systems.
Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.
Fresenius Medical Care is recalling Novalung sensor boxes that are part of the Novalung Console system. These components may display error messages #206 (yellow) or #208 (red) during use, which could indicate a technical failure in the system that provides critical respiratory support.
The Novalung sensor box may show error messages #206 (yellow) or #208 (red) during operation, which could indicate a technical failure in the system. This might affect the accuracy of flow measurement, potentially impacting patient safety during critical respiratory support.
Patients using the Novalung system for long-term (>6 hours) respiratory or cardiopulmonary support are most at risk. The affected units have specific serial numbers ranging from XCONUS0001 to XCONUS0124.
Check if your Novalung sensor box has the product code F30000163 and serial numbers from XCONUS0001 to XCONUS0124. The sensor box is a component of the Novalung Console system used for long-term respiratory support.
Look for error messages #206 (yellow) or #208 (red) on the Novalung system display during use.
Error messages #206 (yellow) and #208 (red) on the Novalung system display indicate potential technical failure in the sensor box.
The product code for the recalled sensor box is F30000163.
Serial numbers from XCONUS0001 to XCONUS0124 are affected.
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-1822-2024 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-1822-2024 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.
