25.02.2025
To the attention of users and distributors of devices monitoring vital functions for patients, Contec CMS8000 and Epsimed MN-120
Following the signalling by cyber security authorities of possible critical backdoor vulnerabilities, that is, accessing the device by an attacker and loading or modifying the files stored on it, endangering data security and system integrity, the National Agency for Medicines and Medical Devices of Romania recommends:
– avoiding the connection of these medical devices to the Internet network;
– permanent monitoring of network traffic to identify signs of suspicious activities – if you keep the device connected to the Internet;
– Emergency transmission to the NAMMDR of any abnormal functioning signals, such as inconsistencies between the patient’s vital functions and its real physical condition, by filling in the Form for reporting serious incidents suspected in relation to medical devices or in vitro diagnostic medical devices – for healthcare professionals, users and patients (https://www.anm.ro/dispozitive-medicale/raporteaza-un-incident/).