International safety notice
Products affected by the Field Action: (i).Brivo NM 615 - 80071260136;
Brazil / Anvisa · BRA · Sep 26, 2014
Key facts
| Title | Products affected by the Field Action: (i).Brivo NM 615 - 80071260136; |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | All Infinia nuclear medicine systems manufactured between 2003 2014: Infinia //// Infinia e-Hawkeye 4 //// All Brivo NM615, Discovery NM630, Optima NM/CT640 and Discovery NM/CT670 systems. The products affected by the Field Action are registered in Brazil as follows: (1).Brivo NM 615 - 80071260136; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO NO BRASIL GE HEALTHCARE DO BRASIL COMÉRCIO E SERVIÇOS PARA EQUIPAMENTOS MEDICOHOSPITALARES LTDA GENERAL ELECTRIC CNPJ 00029372000140 ENDEREÇO AV MAGALHÃES DE CASTRO Nº 4800 13º ANDAR CIDADE JARDIM SÃO PAULOSP TELEFONE 11 30678468 FABRICANTE GE MEDICAL SYSTEMS FUNCTIONAL IMAGING HALFA DBA ELGEMS LTDA HAYOZMA STREET 10 TIRAT HACAMEL ISRAEL |
| Models | 80071260239, NM630, NM615, 80071260122, CT670, 80071260086, CT640, 80071260136, 80071260049 |
| Date | Sep 26, 2014 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
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