International safety notice
Máquinas de diálisis Baxter: Artis, Evosys, Artis Physio, Artis Physio Plus, Innova, Integra, AK 95 S, AK 96, AK 98, AK 200 S y AK 200 ULTRA S. Ver códigos afectados en el Anexo B de la nota de aviso de la empresa
Spain / AEMPS · ESP · Dec 11, 2020
Key facts
| Title | Máquinas de diálisis Baxter: Artis, Evosys, Artis Physio, Artis Physio Plus, Innova, Integra, AK 95 S, AK 96, AK 98, AK 200 S y AK 200 ULTRA S. Ver códigos afectados en el Anexo B de la nota de aviso de la empresa |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | Máquinas de diálisis Baxter: Artis, Evosys, Artis Physio, Artis Physio Plus, Innova, Integra, AK 95 S, AK 96, AK 98, AK 200 S y AK 200 ULTRA S. Ver códigos afectados en el Anexo B de la nota de aviso de la empresa |
| Manufacturer | Gambro Dasco, Italia y Gambro Lundia AB, Suecia |
| Models | 115962, 110648, 114742, 112569, 115401, 955683, 107343, 64066, 109722, 109220, FA-2020-047, 115326 and 49 more |
| Event type | Safety Notice |
| Date | Dec 11, 2020 |
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