International safety notice
Alert 2747 (Technosurveillance) - Philips Medical Systems Ltda - Prodiva 1.5T - Possibility of skin burns due to contact with hot coil cable.
Brazil / Anvisa · BRA · Dec 24, 2018
Key facts
| Title | Alert 2747 (Technosurveillance) - Philips Medical Systems Ltda - Prodiva 1.5T - Possibility of skin burns due to contact with hot coil cable. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Prodiva 1.5T Technical Name: Magnetic Resonance Equipment ANVISA registration number: 10216710351 Risk Class: II Affected model: CX; Affected serial numbers: 83045, 83046, 83047, 82007 and 82006 |
| 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 HEALTHCARE SUZHOU CO LTD Nº258 ZHONG YUAN ROAD SUZHOU INDUSTRIAL PARK 215024 SUZHOU JIANGSU PROVINCE CHINA |
| Models | 83046, 10216710351, 82006, 83045, 83047, 82007 |
| Date | Dec 24, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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