Recalls for Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
2 on file
- Fresenius Medical Care Holdings, Inc.Open, ClassifiedMay 15, 2024
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 Holdings, Inc.Open, ClassifiedUnknown
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.