International safety notice
Alert 2831 (Technosurveillance) Fleximed Comércio e Serviços de Produtos Médicos Hospitalares Ltda HAMILTON-G5 Pulmonary Ventilator Possibility of the ventilator going into Ambient mode.
Brazil / Anvisa · BRA · Mar 25, 2019
Key facts
| Title | Alert 2831 (Technosurveillance) Fleximed Comércio e Serviços de Produtos Médicos Hospitalares Ltda HAMILTON-G5 Pulmonary Ventilator Possibility of the ventilator going into Ambient mode. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: HAMILTON-G5 Lung Ventilator Technical Name: Pressure and Volume Ventilator ANVISA registration number: 10338760041 Risk Class: III Affected model: HAMILTON-G5 Affected serial numbers: 13866, 13865, 13863, 13597, 13583, 13581, 13576, 13575, 13574, 13573, 13571, 13569, 13567, 13566, 13564, 13562, 135 61, 13560, 13559, 13558, 12640, 12421, 12406 , 10314, 10311, 10306, 10305, 10304, 9650, 8491, 8420, 8419, 8417, 8416, 8412, 8409, 8380, 8165, 8160, 7259, 7254, 7253, 7249, 7237, 7188, 7181, 7167, 7102 , 7099, 7084, 7082, 7081, 7076, 7075, 7064, 6963, 6957, 4978, 4254, 2347. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO FLEXIMED COMÉRCIO E SERVIÇOS DE PRODUTOS MÉDICOS HOSPITALARES LTDA CNPJ 64164197000187 RUA IPEROIG Nº 668 PERDIZES SÃO PAULOSP SÃO PAULO SP TEL 11 36725852 EMAIL SALOMAOFLEXIMEDCOMBR FABRICANTE DO PRODUTO HAMILTON MEDICAL AG VIA CRUSCH 8 CH 7402 BONADUZ SWITZERLAND SUÍÇA |
| Models | 13560, 10306, 13571, 13567, 13576, 13581, 12640, 10314, 13566, HAMILTON-G5, 10338760041, 13569 and 18 more |
| Date | Mar 25, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 100–999 Matching device models in FDA data
- 1,000+ 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