International safety notice
Alert 2797 (Technosurveillance) - GE - Centricity Universal Viewer - Possibility that the images displayed on the high-resolution monitors of the IDI Mammo Workstation are not of the patient selected in the Universal Viewer.
Brazil / Anvisa · BRA · Feb 12, 2019
Key facts
| Title | Alert 2797 (Technosurveillance) - GE - Centricity Universal Viewer - Possibility that the images displayed on the high-resolution monitors of the IDI Mammo Workstation are not of the patient selected in the Universal Viewer. |
|---|---|
| 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 Affected serial numbers: Centricity Universal Viewer, model Centricity Universal Viewer (80071260309) |
| 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 |
| Models | 80071260309 |
| Date | Feb 12, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers 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