International safety notice
Alert 2839 (Technosurveillance) Dixtal Biomédica Indústria e Comércio Ltda Dixtal Monitoring Center Software anomaly in the display of Non-Invasive Pressure (PNI) measurements.
Brazil / Anvisa · BRA · Apr 8, 2019
Key facts
| Title | Alert 2839 (Technosurveillance) Dixtal Biomédica Indústria e Comércio Ltda Dixtal Monitoring Center Software anomaly in the display of Non-Invasive Pressure (PNI) measurements. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Dixtal Monitoring Center Technical Name: Vital Signs Monitoring Center ANVISA registration number: 10293490016 Risk Class: III Affected model: N/A Affected serial numbers: See attachment "List of serial numbers at risk". |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO DIXTAL BIOMÉDICA INDÚSTRIA E COMÉRCIO LTDA CNPJ 63736714000182 RUA ANHANDUÍ 520 GALPÃO 6A BAIRRO FLORES MANAUS AMAZONAS MANAUS AMAZONAS TEL 11 995576799 EMAIL TECNIVIGILANCIABRPHILIPSCOM FABRICANTE DO PRODUTO DIXTAL BIOMÉDICA INDÚSTRIA E COMÉRCIO LTDA RUA ANHANDUÍ 520 GALPÃO 6A BAIRRO FLORES MANAUS AMAZONAS BRASIL |
| Models | SBCENCBr16, 10293490016, DX-20CT0-P, DX-20CT1-P, DX-20CT0-N, DX-20CT1-N, 132700726, SBCENCBr12 |
| Date | Apr 8, 2019 |
| 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