International safety notice
Technical name: Planning Software.
Brazil / Anvisa · BRA · Nov 10, 2017
Key facts
| Title | Technical name: Planning Software. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Ergo Stereotactic Planning System Technical name: Planning Software. ANVISA registration number: 80569320022 Risk class: III Modelo afetado: ERGO++ Radiation Treatment Planning Software (+Localyzer) Affected serial numbers: 1.7.3, 1.7.5, 1.7.7, 1.7.8 |
| 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 INC IMPAC MEDICAL SYSTEMS INC 13723 RIVERPORT DRIVE SUITE 100 MARYLAND HEIGHTS MO 63043 TELEFONE 14088308023 EMAIL ELEKTAGLOBALPMSELEKTACOM |
| Models | 1.7.5, 80569320022, 1.7.3, 1.7.8, 1.7.7 |
| Date | Nov 10, 2017 |
| 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