International safety notice
Updated Alert 2701 (Technosurveillance) - GE Healthcare do Brasil, Com. and Serv.
Brazil / Anvisa · BRA · Oct 18, 2018
Key facts
| Title | Updated Alert 2701 (Technosurveillance) - GE Healthcare do Brasil, Com. and Serv. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Family 600 Multiparameter Monitor. Technical Name: Vital Signs Monitor. ANVISA registration number: 80071260346. Product type: Equipment. Risk Class: III. Affected model: OMNI 600, OMNI 610, OMNI 610W, OMNI 612. Affected serial numbers: See updated Installed Base attachment. Access the full content of Alert 2701 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 11 30678436 EMAIL PATRICIASANTANAGECOM FABRICANTE DO PRODUTO GE HEALTHCARE DO BRASIL COM E SERV PARA EQUIPAMENTOS MÉDICOHOSPITALARES LTDA AV VEREADOR JOAQUIM COSTA 1405 GALPÃO 7 CAMPINA VERDE CHICO GRANDE CONTAGEM MG CEP 32150240 BRASIL |
| Models | 80071260346 |
| Date | Oct 18, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers 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