International safety notice
Alert 2646 (Technosurveillance) - Dräger Indústria e Comércio Ltda - Infinity M540 - Possibility of monitor failure when used with the Infinity MCalbe Mainstream CO2 sensor (M11.1) revision 16.
Brazil / Anvisa · BRA · Aug 14, 2018
Key facts
| Title | Alert 2646 (Technosurveillance) - Dräger Indústria e Comércio Ltda - Infinity M540 - Possibility of monitor failure when used with the Infinity MCalbe Mainstream CO2 sensor (M11.1) revision 16. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Infinity M540 Technical Name: Vital Signs Monitor ANVISA registration number: 10407370126 Risk Class: III Affected model: M540 Affected serial numbers: See attachment Affected serial numbers |
| 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 DRÄGER MEDICAL SYSTEM INC 6 TECH DRIVE 01810 ANDOVER MA EUA |
| Models | 10407370126 |
| Date | Aug 14, 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