International safety notice
Alert 2554 (Technosurveillance) GE Healthcare - Angiographic X-ray System / Image-Guided System / Innova Cardiovascular Imaging System The device may experience an x-ray cancellation error during the interventional procedure
Brazil / Anvisa · BRA · Apr 20, 2018
Key facts
| Title | Alert 2554 (Technosurveillance) GE Healthcare - Angiographic X-ray System / Image-Guided System / Innova Cardiovascular Imaging System The device may experience an x-ray cancellation error during the interventional procedure |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Angiographic X-ray System / Image Guided System / Innova Cardiovascular Imaging System Technical name: Hemodynamics and Angiography Equipment / Angiography Equipment / Angiography Equipment ANVISA registration number: 80071260269 Risk class: III Modelo afetado: Discovery IGS IGS 730, Discovery IGS 740 (80071260304) / Innova IGS 520, Innova IGS 530, Innova IGS 540 (80071260269) / Innova IGS 620, Innova IGS 630 (80071260305) Lot numbers/series affected: Discovery IGS IGS 730, Discovery IGS 740 (80071260304) / Innova IGS 520, Innova IGS 530, Innova IGS 540 (80071260269) / Innova IGS 620, Innova IGS 630 (80071260305) |
| 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 GE MEDICAL SYSTEMS SCS RUE DE LA MINIERE 283 BUC FRANÇA |
| Models | 80071260269, 80071260305, 80071260304 |
| Date | Apr 20, 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