International safety notice
Alert 2875 (Technosurveillance) Philips - Efficia Vital Signs Monitor, Efficia Defibrillator/Monitor - Possibility of failure in the ECG cable, causing a reduction in defibrillation energy, failure in energy delivery or electric shock.
Brazil / Anvisa · BRA · May 14, 2019
Key facts
| Title | Alert 2875 (Technosurveillance) Philips - Efficia Vital Signs Monitor, Efficia Defibrillator/Monitor - Possibility of failure in the ECG cable, causing a reduction in defibrillation energy, failure in energy delivery or electric shock. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Efficia Vital Signs Monitor (registration 10216710305); Technical Name: Vital Signs Monitor (registration 10216710305); ANVISA registration number: 10216710305; Risk Class: III Affected model: Registration 10216710305: CM10, CM12, CM100, CM120, CM150 / Registration 10216710313DFM100 Affected serial numbers: All cables produced from 2014 to 2018 |
| 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 | 10216710313, CM150, CM100, 10216710305, 10216710313DFM100, CM120 |
| Date | May 14, 2019 |
| 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