International safety notice
Alert 2519 (Technosurveillance) - Dräger - Fabius Tiro, Fabius Plus XL and Fabius GS Premium Possibility of failure in the device's automatic ventilation system.
Brazil / Anvisa · BRA · Mar 16, 2018
Key facts
| Title | Alert 2519 (Technosurveillance) - Dräger - Fabius Tiro, Fabius Plus XL and Fabius GS Premium Possibility of failure in the device's automatic ventilation system. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome comercial: Fabius Tiro, Fabius Plus XL e Fabius GS Technical name: Anesthesia Device ANVISA registration number: 10407370026; Risk class: III Affected model: Affected serial number: See distribution map |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO DRÄGER INDÚSTRIA E COMÉRCIO LTDA CNPJ 02535707000128 ALAMEDA PUCURUÍ 51 TAMBORÉ BARUERI SP FABRICANTE DRÄGERWERK AG CO KGAA MOISLINGER ALLEE 5355 23542 LÜBECK ALEMANHA TELEFONE 4518825161 EMAIL OLIVERMOELLERDRAEGERCOM |
| Models | 10407370110, 10407370026, 10407370124 |
| Date | Mar 16, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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