International safety notice
Updated Alert 2516 (Technosurveillance) - GE - PACS-IW Possibility of database management error, which may affect the integrity of the acquired images.
Brazil / Anvisa · BRA · Feb 13, 2018
Key facts
| Title | Updated Alert 2516 (Technosurveillance) - GE - PACS-IW Possibility of database management error, which may affect the integrity of the acquired images. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome comercial: Centricity RIS/PACS-IW. Technical name: Software. ANVISA registration number: 80071260105. Product type: Equipment. Risk class: II. Affected model: PACS-IW. Affected serial numbers: HCIT1432299PIW; Access the full content of Alert 2516 with the respective annexes on the ANVISA Portal (http://portal.anvisa.gov.br/alertas). |
| 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 FABRICANTE DYNAMIC IMAGING LLC 40 BOROLINE ROAD ALLENDALE NJ 07401 EUA EMAIL TECNOVIGILANCIABRGECOM |
| Models | 2894128IW, HCIT4118808IW, HCIT1424246PIW, HCIT2882349IW-ARA, 1340485PACS3, 2822655, 80071260105, HCIT4101603PIW, IIS2866984, HCIT1401012PIW, HCIT2882349PW03, HCIT2882349PIW and 19 more |
| Date | Feb 13, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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