International safety notice
Alert 2720 (Technosurveillance): Update - Philips Medical Systems Ltda - Hearstart MRx Defibrillator, Philips brand - Possibility of battery component failure, which may prevent the operation of the MRx Monitor/Defibrillator.
Brazil / Anvisa · BRA · Nov 5, 2018
Key facts
| Title | Alert 2720 (Technosurveillance): Update - Philips Medical Systems Ltda - Hearstart MRx Defibrillator, Philips brand - Possibility of battery component failure, which may prevent the operation of the MRx Monitor/Defibrillator. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Hearstart MRx Defibrillator, Philips brand Technical Name: Defibrillator ANVISA registration number: 10216710136 Risk Class: III Affected model: M3535A, M3536A Affected serial numbers: 18015-0001-P; Note: 31 serial numbers added by the company on 07/04/2019 (total: 32 serial numbers). |
| 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 MEDICAL SYSTEMS 3000 MINUTEMAN ROAD ANDOVER MA 018101099 ESTADOS UNIDOS |
| Models | 18037-0018-P, 18025-0041-P, 18025-0015-P, 18039-0142-P, 18039-0065-P, 18025-0060-P, 18037-0134-P, 18039-0049-P, 18037-0017-P, 18039-0046-P, 18025-0081-P, 18015-0048-P and 23 more |
| Date | Nov 5, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 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