International safety notice
- FabianTM HFO. Nº de modelos: 113001; 112001; 111001; 111001.01 - FabianTM +nCPAP evolution. Nº de modelo: 122001 - FabianTM Therapy evolution. Nº de modelo: 121001
Spain / AEMPS · ESP · Mar 7, 2024
Key facts
| Title | - FabianTM HFO. Nº de modelos: 113001; 112001; 111001; 111001.01 - FabianTM +nCPAP evolution. Nº de modelo: 122001 - FabianTM Therapy evolution. Nº de modelo: 121001 |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | - FabianTM HFO. Nº de modelos: 113001; 112001; 111001; 111001.01 - FabianTM +nCPAP evolution. Nº de modelo: 122001 - FabianTM Therapy evolution. Nº de modelo: 121001 |
| Manufacturer | Acutronic Medical Systems AG, Suiza. |
| Models | 111001.01FABIANTM, 121001, SOFTWARE5.2.2, 112001, 121003.XX, 122001FABIANTM, “SPO₂, 122003.XX, RESPIRADOR7.1.1, 35818-003, 121003.XXFECHA, SISTEMA6.4 and 25 more |
| Event type | Safety Notice |
| Date | Mar 7, 2024 |
At a glance
- No Recall
- Yes Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1