International safety notice
Alert 2682 (Technosurveillance) - GE Healthcare do Brasil, Com. and Serv.
Brazil / Anvisa · BRA · Sep 26, 2018
Key facts
| Title | Alert 2682 (Technosurveillance) - GE Healthcare do Brasil, Com. and Serv. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Millennium MG / Millenium MYOSIGHT Technical Name: Scintigraphic Camera (Gama Camara) ANVISA registration number: 80071260047 / 80071260054 Risk Class: II Affected model: Millennium MG (80071260047) / Millenium MYOSIGHT (80071260054) Affected serial numbers: See attachment "List of lots at risk" |
| 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 11 30678436 EMAIL PATRICIASANTANAGECOM FABRICANTE DO PRODUTO GE MEDICAL SYSTEMS ISRAEL FUNCTIONAL IMAGING ELGEMS LTD 4 HAYOZMA STREET PO BOX 170 TIRAT HACARMEL 30200 ISRAEL ISRAEL |
| Models | 80071260047, 80071260054 |
| Date | Sep 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