International safety notice
Alert 2914 (Technovigilance) - Rectification - GE Healthcare do Brasil - Family of Trunk Cables Possibility of reducing the amount of energy that reaches the patient during defibrillation.
Brazil / Anvisa · BRA · Jun 18, 2019
Key facts
| Title | Alert 2914 (Technovigilance) - Rectification - GE Healthcare do Brasil - Family of Trunk Cables Possibility of reducing the amount of energy that reaches the patient during defibrillation. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: ECG lead wire set. Technical Name: CABLE/ELECTRODE FOR ELECTROCARDIOGRAPH. ANVISA registration number: 80071260396. Risk Class: I. Affected Model: ECG Trunk Cables and ECG Lead Wires (Lead Wire Assemblies with Snap Terminals, Replacement Lead Wires with Snap Terminals, Lead Wire Assemblies with Closure Terminals, and Replacement ECG Lead Wires with Lock Terminals) . Affected serial number: The list of reference/catalog and GTIN codes must be consulted in Appendices A and B, respectively of the Letter to the Customer. Rectification of alert 2914: Change in product identification information, registration number, product name, models, batches/series. Access the full content of Alert 2914 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 HEALTHCARE FINLAND OY KUORTANEENKATU 2 FI00510 HELSINKI FINLÂNDIA |
| Models | 80071260396 |
| Date | Jun 18, 2019 |
| 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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