International safety notice
Alert 2631 (Technosurveillance) - GE Healthcare do Brasil Ltda.
Brazil / Anvisa · BRA · Aug 2, 2018
Key facts
| Title | Alert 2631 (Technosurveillance) - GE Healthcare do Brasil Ltda. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Carescape Ventilator; Technical Name: Lung Ventilator ANVISA registration number: 80071260334; Risk Class: III Affected model: Carescape R860; Affected serial numbers: see List of lots at risk. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO GE HEALTHCARE DO BRASIL COM E SERV PARA EQUIPAMENTOS MÉDICOHOSPITALARES LTDA AV MAGALHÃES DE CASTRO Nº 4800 11º ANDAR CIDADE JARDIM SÃO PAULO SP TEL 11 30678436 EMAIL PATRICIASANTANAGECOM FABRICANTE DO PRODUTO DATEXOHMEDA INC 3030 OHMEDA DRIVE MADISON WI |
| Models | 80071260230, 80071260334 |
| Date | Aug 2, 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