International safety notice
Alert 2921 (Technosurveillance) - GE Healthcare do Brasil - Computed Tomography System Possibility of additional exposure at low doses.
Brazil / Anvisa · BRA · Jul 9, 2019
Key facts
| Title | Alert 2921 (Technosurveillance) - GE Healthcare do Brasil - Computed Tomography System Possibility of additional exposure at low doses. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Computed Tomography System Technical Name: Computed Tomography Equipment ANVISA registration number: 80071260343 Risk Class: III Affected model: Revolution CT and Revolution CT ES Affected serial numbers: REVVX1600015CN; |
| 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 TECNOVIGILANCIABRASILGECOM FABRICANTE DO PRODUTO GE MEDICAL SYSTEMS LLC 3000 N GRANDVIEW BLVD WAUKESHA WI 53188 EUA ESTADOS UNIDOS |
| Models | CT443038CN5, 80071260343, CT441683CN0, REVVX1800104CN, REVVX1600015CN |
| Date | Jul 9, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 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