International safety notice
Alert 2494 (Technosurveillance) - GE Healthcare - Carestation Anesthesia System Image processor failure
Brazil / Anvisa · BRA · Feb 27, 2018
Key facts
| Title | Alert 2494 (Technosurveillance) - GE Healthcare - Carestation Anesthesia System Image processor failure |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Ultrasound System Technical name: Ultrasound Device ANVISA registration number: 80372200002 Risk class: II Affected model: MyLab70 XVG; Trade name: Carestation Anesthesia System Technical name: Lung Ventilator ANVISA registration number: 80071260334 Risk class: III Affected model: Carescape R860 Affected serial numbers: See attached list |
| 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 FABRICANTE DATEXOHMEDA INC 3030 OHMEDA DRIVE MADISON WI ESTADOS UNIDOS TELEFONE 1 6082133656 EMAIL TECNOVIGILANCIABRGECOM |
| Models | 80071260334, MyLab60, 80372200002, MyLab70 |
| Date | Feb 27, 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