International safety notice
Alert 2794 Update (Technosurveillance) - GE Healthcare do Brasil - Carescape Ventilator - Possibility of loss of ventilation due to disconnection of the ISG from the respiratory circuit pathway and the ventilator outlet port.
Brazil / Anvisa · BRA · Feb 4, 2019
Key facts
| Title | Alert 2794 Update (Technosurveillance) - GE Healthcare do Brasil - Carescape Ventilator - Possibility of loss of ventilation due to disconnection of the ISG from the respiratory circuit pathway and the ventilator outlet port. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Carescape Ventilator. Access the full content of Alert 2794 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 DATEXOHMEDA INC ESTADOS UNIDOS ENDEREÇO 3030 OHMEDA DRIVE MADISON WI |
| Models | 5456891, 5459897, 50041754, 5456467, 5459995, 5472847, 5474035, 5465941, 5472400, 5472653, 5470506, 5472846 and 18 more |
| Date | Feb 4, 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