International safety notice
Magnetic Resonance Imaging System
Brazil / Anvisa · BRA · Mar 13, 2015
Key facts
| Title | Magnetic Resonance Imaging System |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | MAGNETIC RESONANCE IMAGING SYSTEM, Models and records: SEE LETTER TO THE CUSTOMER. This fix applies to units of the following GE Healthcare MRI systems: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T , Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w, Signa Profile and Signa Ovation. |
| Manufacturer | DETENTOR DO REGISTRO GE HEALTHCARE DO BRASIL CNPJ 00 029 372 0001 40 ENDEREÇO AV MAGALHÃES DE CASTRO Nº 4800 13º ANDAR CIDADE JARDIM SÃO PAULO FABRICANTE GE MEDICAL SYSTEMS LLC ENDEREÇO 3200 N GRANDVIEW BLVP WAUKESHA WI 53188 ESTADOS UNIDOS |
| Models | MR450w, MR750W, MR450, MR355, MR750, MR360 |
| Date | Mar 13, 2015 |
| 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