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Critical vulnerabilities in operating systems of different manufacturers

2019.10.09

Ref.: 10746/19

BfArM refers to a publication about potential cybersecurity vulnerabilities in operating systems of different manufacturers issued by FDA:

https://www.fda.gov/news-events/press-announcements/fda-informs-patients-providers-and-manufacturers-about-potential-cybersecurity-vulnerabilities

Medical device manufacturers using these operating systems must implement risk mitigation measures based on their updated risk analysis in light of this vulnerability; see also our recommendation of 28.8.2019 (

Critical vulnerabilties in the real-time operating system VxWorks of the company Wind River
).

In case of questions please contact:

Federal Institute for Drugs and Medical Devices
Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Telephone: +49 (0)228 99 307-5384 (active medical devices and in vitro diagnostics)
Facsimile: +49 (0)228 99 307-5300
E-Mail: md-vigilance@bfarm.de