International safety notice
Alert 2751 Updated (Technosurveillance) - GE Healthcare do Brasil - Magnetic Resonance Imaging System (various products) - The latest version of the software may not have been correctly reinstalled after maintenance.
Brazil / Anvisa · BRA · Dec 27, 2018
Key facts
| Title | Alert 2751 Updated (Technosurveillance) - GE Healthcare do Brasil - Magnetic Resonance Imaging System (various products) - The latest version of the software may not have been correctly reinstalled after maintenance. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Signa Openspeed Magnetic Resonance Imaging System; Technical Name: Magnetic Resonance Equipment. ANVISA registration number: 80071260044; Product type: Equipment. Risk Class: II. Affected model: OpenSpeed standards (80071260044); Affected serial numbers: See attachment Updated list of serial numbers at risk. Alert Update: List of serial numbers at risk. Access the full content of Alert 2751 with the respective annexes on the ANVISA Portal (http://portal.anvisa.gov.br/alertas). |
| 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 MEDICAL SYSTEMS LLC 3200 NORTH GRANDVIEW BOULEVARD WUAKESHA WISCONSIN 53188 ESTADOS UNIDOS |
| Models | MR355, MR360, 80071260352, 80071260103, 80071260125, 80071260044, 80071260039, 80071260077, 80071260040, 80071260033, 80071260031, 80071260126 and 1 more |
| Date | Dec 27, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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About International device safety notices
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