International safety notice
Vital signs monitor/ Pressure Lung Ventilator/ Anesthesia device.
Brazil / Anvisa · BRA · Apr 20, 2015
Key facts
| Title | Vital signs monitor/ Pressure Lung Ventilator/ Anesthesia device. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | VITAL SIGNS MONITOR CARDIOCAP 5, Risk class III, Registration: 80071260203. Affected Product: D-Fend/D-Fend+ Moisture Condensers used with E/M-C(Ai)O(V)(X) Compact Respiratory Gas Modules and Cardiocap/5 monitors. Affected batches of Moisture Condensers: D-Fend (Números de Peça): 876446-HEL: J9964985, J10201698, J10258248, J10284871, J10284872, J10344108 ///// D-Fend+ (Part Numbers): 881319-HEL: J9906966, J9965152, J10258251, J10300071 //////////// Products that can use Compact Respiratory Gas Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors are registered with ANVISA as: VITAL SIGNS MONITOR::::: Product: Carescape Monitor, Model: B850 - ANVISA Registration: 80071260167 //// Product: Patient Monitor, Model: Carescape B650 - ANVISA Registration: 80071260166 //// Product: Carescape Modular Monitor Model: B450 - ANVISA Registration: 80071260333 //// Product: Cardiocap/5 - ANVISA Registration: 80071260203 //// PRESSURE LUNG VENTILATOR:::: Carescape Ventilator, Model: Carescape R860 - ANVISA Registration: 80071260334 //// Product: Engstrom Carestation Intensive Care Ventilator - ANVISA Registration: 80071260230 //// ANESTHESIA APPARATUS::::: Product : Avance Anesthesia system Model: Avance CS2 and Avance Pro - ANVISA Registration: 80071260306 //// Product: Anesthesia Device, Model: Aisys - ANVISA Registration: 80071260272 |
| Manufacturer | DETENTOR DO REGISTRO GE HEALTHCARE DO BRASIL CNPJ 00 029 372 0001 40 ENDEREÇO AV MAGALHÃES DE CASTRO Nº 4800 13º ANDAR CIDADE JARDIM SÃO PAULO FABRICANTE GE HEALTHCARE FINLAND OY ENDEREÇO KUORTANEENKATU 2 VALLILA HELSINKI FINLÂNDIA |
| Models | 80071260272, 881319-HEL, 80071260167, J9906966, 80071260334, J9965152, J10284871, J9964985, J10344108, J10201698, J10258248, 876446-HEL and 8 more |
| Date | Apr 20, 2015 |
| 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