Alerta De Seguridad para Product name: Vital Signs Monitor ### Anvisa Record Number: 10216710215 ### Risk Class: III (High Risk) ### Affected Models: MX400, MX430 , MX450, MX500, MX550 ### Affected serial numbers: APPENDIX

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 to Users and Patients: Until software is updated, users should turn off and on affected devices monthly, especially if the user does not completely turn off the device when no patient is being monitored. Review this information with all team members who need to be aware of the content of this release. It is important to understand the implications of this release. A Philips Healthcare representative will contact customers with the affected devices to arrange for the software update installation. If you have any questions or concerns regarding this correction, please contact your local Philips dealer or our Philips Customer Service Center at 0800-701-7789. Service from Monday to Saturday from 07 to 19h. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link