International safety notice
Alert 2696 (Technosurveillance) - GE Healthcare - Patient Monitor - Possibility of restart due to network overload caused by network configuration error.
Brazil / Anvisa · BRA · Oct 11, 2018
Key facts
| Title | Alert 2696 (Technosurveillance) - GE Healthcare - Patient Monitor - Possibility of restart due to network overload caused by network configuration error. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Patient Monitor Technical Name: Vital Signs Monitor ANVISA registration number: 80071260135 / 80071260387 Risk Class: III Affected model: B20 and B40 / B105 and B125 Affected serial numbers: See attachment "List of serial numbers/batches 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 CHINA CO LTD GE MEDICAL SYSTEMS CHINA CO LTD N 19 CHANGJIANG ROAD WUXI NATIONAL HITECH DEVELOPMENT ZONE JIANGSU PR CHINA 214028 CHINA |
| Models | 80071260135, 80071260387 |
| Date | Oct 11, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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