International safety notice

Alert 2721 (Technosurveillance) - GE Healthcare do Brasil - Giraffe Incubator - Possibility of contamination if the canopy seals are not adequately sanitized.

Brazil / Anvisa · BRA · Nov 6, 2018

Key facts

Title Alert 2721 (Technosurveillance) - GE Healthcare do Brasil - Giraffe Incubator - Possibility of contamination if the canopy seals are not adequately sanitized.
Regulator Brazil / Anvisa
Country BRA
Brand Trade Name: Giraffe Incubator Technical Name: Incubator ANVISA registration number: 80071260158 Risk Class: III Affected model: Giraffe Omnibed Affected serial numbers: HDGK51441;
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 DO PRODUTO OHMEDA MEDICAL INC 8880 GORMAN ROAD LAUREL MD 20723 USA ESTADOS UNIDOS
Models HDGK51442, 80071260158, HDGK51441
Date Nov 6, 2018
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

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