Name: HeartStart - ANVISA Registration Number: 10216710136 and 10216710271 - Technical Name: Defibrillator - Risk Class: III - High Risk - Model Affected: MRx and XL + - Affected Series Numbers: Affected Series in ANNEX 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Recommendations for Users and Patients: Before receiving a replacement sync cable, you can continue to use the affected sync cables as long as they are used only to connect the ECG output plug on the monitor / defibrillator to the (input) port of the ECG on a bed monitor. The issues described in this letter do not impact this application of the sync cable. The affected sync cables should not be used to connect the ECG output plug of a bed monitor to the ECG (input) port on the monitor / defibrillator. Philips will replace all affected sync cables with a new cable for free. A Philips Healthcare representative will contact customers with the affected devices to arrange replacement. If you find it difficult to follow the instructions contained in this release, please contact our Philips Solution Center at 0800-701-7789. Service from Monday to Saturday from 07h to 19h.