International safety notice
Alert 2764 (Technosurveillance) - GE Healthcare do Brasil - Digital Mammography System - Senographe Crystal Nova - Possibility of patient exams being mixed.
Brazil / Anvisa · BRA · Jan 11, 2019
Key facts
| Title | Alert 2764 (Technosurveillance) - GE Healthcare do Brasil - Digital Mammography System - Senographe Crystal Nova - Possibility of patient exams being mixed. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Digital Mammography System Technical Name: Mammography Device ANVISA registration number: 80071260357 Risk Class: III Affected model: Senographe Crystal Nova Affected serial numbers: all Senographe Crystal Nova |
| 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 | 80071260357 |
| Date | Jan 11, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
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