International safety notice
Alert 2746 (Technosurveillance) - Philips - Efficia Vital Signs Monitor, Efficia Defibrillator/Monitor - Possibility of failure in the ECG cable, causing a reduction in defibrillation energy or failure in energy delivery.
Brazil / Anvisa · BRA · Dec 21, 2018
Key facts
| Title | Alert 2746 (Technosurveillance) - Philips - Efficia Vital Signs Monitor, Efficia Defibrillator/Monitor - Possibility of failure in the ECG cable, causing a reduction in defibrillation energy or failure in energy delivery. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Efficia Vital Signs Monitor; Technical Name: Vital Signs Monitor; ANVISA registration number: 10216710305; Risk Class: III Affected Model: CM10, CM12, CM100, CM120, CM150/DFM100 Affected serial numbers: See attachment Serial numbers at risk |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO PHILIPS MEDICAL SYSTEMS LTDA CNPJ 58295213000178 AV MARCOS PENTEADO DE ULHOA RODRIGUES 401 SETOR PARTE 39 TAMBORÉ BARUERI SÃO PAULO TEL 11 975763608 EMAIL LARISSAFRIASPHILIPSCOM FABRICANTE DO PRODUTO PHILIPS GOLDWAY SHENZHEN INDUSTRIAL INC NO2 KEJI NORTH 3RD ROAD NANSHAN DISTRICT 518057 SHENZHEN REPÚBLICA POPULAR DA CHINA |
| Models | CM100, 10216710313, DFM100, CM120, CM150, 10216710305 |
| Date | Dec 21, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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