International safety notice
Alert 2748 (Technosurveillance) - GE Healthcare - Magnetic Resonance Imaging System - Manuals were not provided in all local languages;
Brazil / Anvisa · BRA · Dec 26, 2018
Key facts
| Title | Alert 2748 (Technosurveillance) - GE Healthcare - Magnetic Resonance Imaging System - Manuals were not provided in all local languages; |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Magnetic Resonance Imaging System Technical Name: Magnetic Resonance Equipment ANVISA registration number: 80071260352 Risk Class: II Affected model: Signa Creator and Signa Explorer Números de série afetados: MRR11559; GON4631927; MRR11031; MRR11087; MRR11038; MRR11108; MRR11057; MRR11081; MRR11178; MRR11177; MRR11187; MRR11186; MRR11088; MRR10693A; MRR1183; MRR11181; MRR11223; MRR11241; MRR11242; MRR11251; MRR11250; MRR11188; MRR11258; MRR11293; MRR11065A; MRR11297; MRR11288; MRR11358; MRR11372; MRR11375; MRR11382; MRR11404; MRR11391; MRR11395; MRR11243; MRR11456; MRR11466; MRR11458; MRR11471; GON4483928. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO GE HEALTHCARE DO BRASIL COM E SERV PARA EQUIPAMENTOS MÉDICOHOSPITALARES LTDA CNPJ 00029372000140 AV MAGALHÃES DE CASTRO Nº 4800 11º ANDAR CIDADE JARDIM SÃO PAULO SP TEL 3004 2525 CAPITAIS E REGIÕES METROPOLITANAS 0800 165 799 DEMAIS REGIÕES EMAIL TECNOVIGILANCIABRASILGECOM FABRICANTE DO PRODUTO GE HEALTHCARE TIANJIN COMPANY LIMITED NO266 JINGSAN ROAD TIANJIN AIRPORT ECONOMIC AREA TIANJIN 300308 CHINA |
| Models | MRR11178, MRR11466, MRR11242, MRR11081, MRR11358, MRR11181, MRR11297, MRR11288, MRR11087, MRR11057, MRR11223, MRR11456 and 29 more |
| Date | Dec 26, 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