International safety notice
Alert 2911 (Technovigilance) - GE Healthcare do Brasil - Centricity Universal Viewer Possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images.
Brazil / Anvisa · BRA · Jun 13, 2019
Key facts
| Title | Alert 2911 (Technovigilance) - GE Healthcare do Brasil - Centricity Universal Viewer Possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Centricity Universal Viewer Technical Name: Software ANVISA registration number: 80071260309 Risk Class: II Affected model: Centricity Universal Viewer based on Centricity PACS 6.0 SP9 or greater used in combination with Centricity PACS 6.0 SP9 or greater. Affected serial numbers: HCIT4214173UV, HCIT7125379CPACS. |
| 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 3004 2525 CAPITAIS E REGIÕES METROPOLITANAS 0800 165 799 DEMAIS REGIÕES EMAIL TECNOVIGILANCIAGECOM FABRICANTE DO PRODUTO GE HEALTHCARE 500 W MONROE ST CHICAGO IL 60661 ESTADOS UNIDOS ESTADOS UNIDOS |
| Models | HCIT4214173UV, 80071260309, HCIT7125379CPACS |
| Date | Jun 13, 2019 |
| 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