Novalung System
XENIOS AG · Model Novalung console · UDI-DI 04057224902043
QJZ
Prescription
1
510(k) clearances
533
Adverse events (29 deaths)
2
Recalls
8
Facilities
Description
The Novalung System, consisting of the Novalung console and XLung kit, is a blood oxygenation and carbon dioxide removal system designed to provide extracorporeal cardiac and/or pulmonary support.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-08 | Fresenius Medical Care Holdings, Inc. | 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) techn |
| 2021-12-07 | Fresenius Medical Care Holdings, Inc. | 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 i |
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