International safety notice
Acutronic
United Kingdom / MHRA · GBR · Nov 30, 2021
Key facts
| Title | Acutronic |
|---|---|
| Regulator | United Kingdom / MHRA |
| Country | GBR |
| Brand | Fabian HFO, +nCPAP Evolution, Therapy Evolution (Update to FSN 26 to 30 July 2021) |
| Manufacturer | Acutronic |
| Models | 112001, 447297098, 111001.01, CH-8816, 122001, 122012, FSCA-21-002_FSCA-21-003-FSN-2, FSCA-18-004, 111001, FSCA-21002_FSCA-21-003-FSN-1, FSCA-20-001, 5.2.1 and 7 more |
| Event type | Safety Notice |
| Action type | Field safety notice |
| Date | Nov 30, 2021 |
| Regulator page | gov.uk |
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