International safety notice
Alert 2836 (Technosurveillance) GE Healthcare do Brasil Aisys Anesthesia System, Aisys Anesthesia Device Possibility that the concentration of the agent decreases rapidly, which may result in the reestablishment of consciousness.
Brazil / Anvisa · BRA · Apr 4, 2019
Key facts
| Title | Alert 2836 (Technosurveillance) GE Healthcare do Brasil Aisys Anesthesia System, Aisys Anesthesia Device Possibility that the concentration of the agent decreases rapidly, which may result in the reestablishment of consciousness. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Aisys Anesthesia System (80071260326); Technical Name: Anesthesia Device ANVISA registration number: 80071260326; Risk Class: III Affected model: Aisys CS2 Affected serial numbers: 5478265-1; |
| 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 DATEXOHMEDA INC ENDEREÇO 3030 OHMEDA DRIVE MADISON WI |
| Models | APWX00556, APWX00362, APWX00555, 5478265-2, APWX01600, APWX00557, 5478265-3, 5478265-1, software11SP01, 11SP02, 5478265-4, 11SP01 and 6 more |
| Date | Apr 4, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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