International safety notice
Technical name: Magnetic Resonance Equipment
Brazil / Anvisa · BRA · Aug 21, 2016
Key facts
| Title | Technical name: Magnetic Resonance Equipment |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Signa Excite Technical name: Magnetic Resonance Equipment ANVISA registration number: 80071260081 Risk class: II Affected model: HDx 1.5T and HDx 3.0T Affected serial numbers: All versions of CADstream when used within the SureLoc application, and all versions of CADstream prior to version 5.2.6 when used in conjunction with PURE. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO GE HEALTHCARE DO BRASIL COM E SERV PARA EQUIPAMENTOS MÉDICOHOSPITALARES LTDA ENDEREÇO AV MAGALHÃES DE CASTRO Nº 4800 13º ANDAR CIDADE JARDIM SP TELEFONE 11 30678436 FABRICANTE GE HEALTHCARE E GE MEDICAL SYSTEMS LLC PAÍS ESTADOS UNIDOS |
| Models | 80071260121, 5.2.6, 80071260081 |
| Date | Aug 21, 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