International safety notice
Alert 2497 (Technosurveillance) - Brainlab - Exactrac Location System Incorrect interpretation of beam authorization
Brazil / Anvisa · BRA · Feb 27, 2018
Key facts
| Title | Alert 2497 (Technosurveillance) - Brainlab - Exactrac Location System Incorrect interpretation of beam authorization |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Exactrac Location System Technical name: Stereotactic System ANVISA registration number: 80042070004 Risk class: III Affected model: Affected serial number: 8596415001; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BRAINLAB LTDA CNPJ 02981566000117 AVENIDA ANGÉLICA 2071 SALA 41 42 47 E 48 CONSOLAÇÃO SÃO PAULO SP FABRICANTE BRAINLAB AG OLOFPALMESTRASSE 9 81829 MUNICH ALEMANHA TELEFONE 49 89 99 15 68 5033 EMAIL BRAINLABVIGILANCEBRAINLABCOM |
| Models | 80042070004, 202616001, 8596415001 |
| Date | Feb 27, 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