International safety notice
Technical Name: Radiosurgery System
Brazil / Anvisa · BRA · Apr 14, 2016
Key facts
| Title | Technical Name: Radiosurgery System |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Leksell Gamma Knife® ## ANVISA registration number: 80569320006 ## Risk class: III ## Model(s) affected: Leksell Gamma Knife PERFEXION ## Serial number(s) affected: LEKSELL GAMMA KNIFE PERFEXION/17397-001/6158 and LEKSELL GAMMA KNIFE PERFEXION/105528-001/6122. |
| Manufacturer | DADOS DO DETENTOR DO REGISTRO DO PRODUTO NO BRASIL ELEKTA MEDICAL SYSTEMS COMÉRCIO E SERVIÇOS PARA RADIOTERAPIA LTDA CNPJ 09528196000166 RUA CARNEIRO DA CUNHA 303 1º ANDAR VILA DA SAÚDECEP 04144000 SÃO PAULOSP TELEFONE PARA CONTATO 11 50544550 EMPRESA FABRICANTE ELEKTA INSTRUMENT AB ENDEREÇO PO BOX 7593 KUNGSTENSGATAN 18 SE10393 STOCKHOLM ESTOCOLMOSUÉCIA |
| Models | 105528-001, 17397-001, 80569320006 |
| Date | Apr 14, 2016 |
| 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