International safety notice
Alert 2681 (Technosurveillance) - Auto Suture do Brasil Ltda - Capnostream®20p, Portable Capnography Monitor - Date/time, nurse call and alarm settings may reset to factory settings.
Brazil / Anvisa · BRA · Sep 25, 2018
Key facts
| Title | Alert 2681 (Technosurveillance) - Auto Suture do Brasil Ltda - Capnostream®20p, Portable Capnography Monitor - Date/time, nurse call and alarm settings may reset to factory settings. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Capnostream®20p, Portable Capnography Monitor Technical Name: OXICAPNOGRAPH ANVISA registration number: 10349000534 Risk Class: III Affected model: CS08651-03; Affected serial numbers: P801175577 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO AUTO SUTURE DO BRASIL LTDA CNPJ 01645409000128 AV JORNALISTA ROBERTO MARINHO 85 11º ANDAR CEP 04675010 SÃO PAULO SP TEL 11 21829200 EMAIL TECNOVIGILANCIACOVIDIENCOMNATALIAJMAIAMEDTRONICCOM FABRICANTE DO PRODUTO ORIDION MEDICAL 1987 LTD HAR HOTZVIM SCIENCEBASED INDUSTRIAL PARK 7 HAMARPE ST PO BOX 45025 ISRAEL |
| Models | 10349000534, Capnostream®20p, CS08651-03, P801175577, CS08657-03, CS08658-03, CS08652-03 |
| Date | Sep 25, 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