International safety notice
Alert 2588 (Technosurveillance) - Dräger Indústria e Comércio Ltda - Fabius Tiro and Fabius Plus XL - The affected devices can administer 100% N2O to the patient.
Brazil / Anvisa · BRA · Jun 13, 2018
Key facts
| Title | Alert 2588 (Technosurveillance) - Dräger Indústria e Comércio Ltda - Fabius Tiro and Fabius Plus XL - The affected devices can administer 100% N2O to the patient. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Fabius Tiro; Technical Name: Anesthesia Device ANVISA registration number: 10407370026 and 10407370110 Risk Class: III Affected model: Fabius Tiro; Affected serial numbers: See Table 1 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO DRÄGER INDÚSTRIA E COMÉRCIO LTDA CNPJ 02535707000128 ALAMEDA PUCURUÍ 51 TAMBORÉ BARUERI SP TEL 11 46894415 EMAIL DENISESOUZADRAEGERCOM FABRICANTE DO PRODUTO DRÄGERWERK AG CO KGAA MOISLINGER ALLEE 5355 23542 LÜBECK ALEMANHA |
| Models | 10407370110, 10407370026 |
| Date | Jun 13, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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