International safety notice
Alert 2723 (Technosurveillance) - GE Healthcare - Aisys Anesthesia System - Possibilities of non-functional backup ventilation after cycling procedure and inability to define fresh gas settings.
Brazil / Anvisa · BRA · Nov 7, 2018
Key facts
| Title | Alert 2723 (Technosurveillance) - GE Healthcare - Aisys Anesthesia System - Possibilities of non-functional backup ventilation after cycling procedure and inability to define fresh gas settings. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Aisys Anesthesia System 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 11 30678436 EMAIL PATRICIASANTANAGECOM FABRICANTE DO PRODUTO DATEXOHMEDA INC ESTADOS UNIDOS ENDEREÇO 3030 OHMEDA DRIVE MADISON WI |
| Models | APWX00558, APWX00554, APWX01639, APWX00557, 5478265-3, APWX00362, APWX00555, APWX01643, APWX01641, APWX01644, APWX00556, 5478265-4 and 8 more |
| Date | Nov 7, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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