Fresenius Medical Care recalls Novalung Sensor Box (F30000163) due to potential communication errors between flow sensor and sensor box, which may cause disabled flow measurement and air bubble detection during respiratory support.
Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection.
Fresenius Medical Care is recalling Novalung Sensor Box components (F30000163) that are part of the Novalung Console system. These devices may show error messages 206 (yellow) or 208 (red) indicating communication issues between the flow sensor and sensor box, which could lead to incorrect flow measurements and air bubble detection during critical respiratory support.
The sensor box may communicate errors with the flow sensor during use, causing the system to fail in measuring blood flow and detecting air bubbles. This could lead to incorrect treatment of patients requiring critical respiratory support.
Patients using the Novalung Console system for long-term (>6 hours) respiratory or cardiopulmonary support are most at risk. The affected units have specific serial numbers listed in the recall notice.
Check if your Novalung Sensor Box has the serial numbers listed in the recall (e.g., XCONUS0013, XCONUS0079, etc.). The product is part of the Novalung Console system used for long-term respiratory support in adults.
Look for error messages 206 (yellow) or 208 (red) on the Novalung Console system, which indicate communication issues between the flow sensor and sensor box.
Reach out to Fresenius Medical Care to confirm if your specific Novalung Sensor Box is affected by the recall and to get instructions for next steps.
Error messages 206 (yellow) and 208 (red) on the Novalung Console system indicate communication issues between the flow sensor and sensor box.
Check if your Novalung Sensor Box has a serial number listed in the recall (e.g., XCONUS0013, XCONUS0079, etc.).
No, but you should check for error messages and contact Fresenius Medical Care to confirm if your device is 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-0562-2022 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-0562-2022 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.
