International safety notice
Alert 2768 (Technosurveillance) - GE Healthcare do Brasil - Logiq P6 Ultrasound System - Possibility of increased temperature of the probe head when the digitizer is used with specific probes.
Brazil / Anvisa · BRA · Jan 14, 2019
Key facts
| Title | Alert 2768 (Technosurveillance) - GE Healthcare do Brasil - Logiq P6 Ultrasound System - Possibility of increased temperature of the probe head when the digitizer is used with specific probes. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Logiq P6 Ultrasound System Technical Name: Ultrasound device ANVISA registration number: 80071260171 Risk Class: II Affected model: Logiq P6 Affected serial numbers: Logiq P6 with SW versions R1.0.x (BT07) and R2.0.x (BT09) |
| 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 ULTRASOUND KOREA LTD 9 SUNHWANRO 214BEONGIL JUNGWONGU SEONGNAMSI GYEONGGIDO CORÉIA DO SUL COREIA DO SUL |
| Models | R1.0.x, 80071260171, R2.0.x |
| Date | Jan 14, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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