International safety notice
Alert 2632 (Technosurveillance) - GE Healthcare do Brasil.
Brazil / Anvisa · BRA · Aug 2, 2018
Key facts
| Title | Alert 2632 (Technosurveillance) - GE Healthcare do Brasil. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Magnetic Resonance Imaging System; Technical Name: Magnetic Resonance Equipment ANVISA registration number: 80071260033; Risk Class: II Modelo afetado: Signa Infinity Twinspeed, 1.5 T Signa Infinity; MR Signa Excite 3.0T; Signa Excite Hd 1.5T, Signa Excite HD 3.0T; Signa Excite Modelos: HDX 1.5t e HDX 3.0t; Signa HDXT 3.0t e Signa HDXT 1.5t; Signa HDI Affected serial numbers: see attachment List of serial numbers at risk |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO GE HEALTHCARE DO BRASIL COM E SERV PARA EQUIPAMENTOS MÉDICOHOSPITALARES LTDA AV MAGALHÃES DE CASTRO Nº 4800 11º ANDAR CIDADE JARDIM SÃO PAULO SP TEL 11 30678436 EMAIL TECNOVIGILANCIABRGECOM FABRICANTE DO PRODUTO GE MEDICAL SYSTEMS ESTADOS UNIDOS DA AMÉRICA GE MEDICAL SYSTEMS LLC ESTADOS UNIDOS DA AMÉRICA GE MEDICAL SYSTEMS LLC ESTADOS UNIDOS DA AMÉRICA GE HEALTHCARE ESTADOS UNIDOS DA AMÉRICA GE HEALTHCARE DO BRASIL COMERCIO E SERVIÇOS PARA EQUIPAMENTOS MÉDICOHOSPITALARES LTDA BRASIL E GE MEDICAL SYSTEMS LLC ESTADOS UNIDOS DA AMÉRICA GE MEDICAL SYSTEMS LLC ESTADOS UNIDOS DA AMÉRICA E GE MAGNETS ESTADOS UNIDOS DA AMÉRICA E GE HEALTHCARE ESTADOS UNIDOS DA AMÉRICA |
| Models | 80071260088, 80071260102, 80071260103, 80071260081, 80071260033, 80071260061 |
| Date | Aug 2, 2018 |
| 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