International safety notice

Alert 2898 (Technosurveillance) GE Healthcare do Brasil - X-Ray Systems Possibility of aging monitors falling.

Brazil / Anvisa · BRA · Jun 5, 2019

Key facts

Title Alert 2898 (Technosurveillance) GE Healthcare do Brasil - X-Ray Systems Possibility of aging monitors falling.
Regulator Brazil / Anvisa
Country BRA
Brand Trade Name: Prestige II X-ray System (80071260010); Technical Name: Fixed X-ray Device ANVISA registration number: 80071260010; Risk Class: III Affected model: N/A Affected serial numbers: 00000127882BU9;
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 MEDICAL SYSTEMS ESTADOS UNIDOS DA AMÉRICA 3000 NOTH GRANDVIEW BOULEVARD WAUKESHA WI 53188 ESTADOS UNIDOS
Models 00000000003584, HS030921C00017, 00000127882BU9, 80071260012, 80071260005, 00000000001130, 00000129368BU7, 80071260010, 10310650014, 00000090048BU0
Date Jun 5, 2019
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 1,000+ Matching device models in FDA data
  • 100–999 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

Browse all International device safety notices