International safety notice
Technical name: Linear Accelerator
Brazil / Anvisa · BRA · Jan 18, 2018
Key facts
| Title | Technical name: Linear Accelerator |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Elekta Linear Accelerator Technical name: Linear Accelerator ANVISA registration number: 80569320007 Risk class: III Affected model: Integrity R1.2. Affected serial numbers: See attached list of affected lots on the Anvisa portal - link: http://portal.anvisa.gov.br/informacoes-tecnicas13/-/asset_publisher/WvKKx2fhdjM2/content/alerta-2472-tecnovigilancia-elekta- linear-accelerator-elekta-positioning-error-after-movimento-automatico-da-tabela/33868?p_p_auth=2S7eIMsb&inheritRedirect=false&redirect=http%3A%2F%2Fportal.anvisa.gov.br%2Finformacoes-tecnicas13%3Fp_p_auth% 3D2S7eIMsb%26p_p_id%3D101_INSTANCE_WvKKx2fhdjM2%26p_p_lifecycle%3D0%26p_p_state%3Dnormal%26p_p_mode%3Dview%26p_p_col_id%3Dcolumn-3%26p_p_col_pos%3D1%26p_p_col_count%3 D5 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ELEKTA MEDICAL SYSTEMS COMÉRCIO E SERVIÇOS RADIOTERAPIA LTDA CNPJ 09528196000166 RUA CARNEIRO DA CUNHA 303 1º ANDAR VILCA DA SAÚDE CEP 04144000 SÃO PAULO SP FABRICANTE ELEKTA LTD LINAC HOUSE FLEMING WAY CRAWLEY WEST SUSSEX RH10 9RR REIO UNIDO EMAIL ELEKTAGLOBALPMSELEKTACOM |
| Models | 2Fportal.anvisa.gov.br, 3D2S7eIMsb, 3D101_INSTANCE_WvKKx2fhdjM2, 26p_p_lifecycle, 3Fp_p_auth, 26p_p_col_pos, WvKKx2fhdjM2, alerta-2472-tecnovigilancia-elekta-acelerador-linear-elekta-erro-de-posicionamento-apos-movimento-automatico-da-tabela, 3Dnormal, 26p_p_state, 2Finformacoes-tecnicas13, 3Dview and 8 more |
| Date | Jan 18, 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