FDA issues warning about Urgent/11 vulnerabilities putting critical medical devices at risk

The U.S. Food and Drug Administration is warning healthcare providers and device manufacturers about potentially serious security flaws that may introduce risks for hospital networks and thousands of medical devices.

The security flaws can be traced back to a network protocol created nearly two decades ago that became an industry standard.

The FDA is not aware of any confirmed adverse events related to these vulnerabilities. However, software to exploit these vulnerabilities is already publicly available, the agency said in a safety advisory issued Tuesday. Devices determined to be affected so far include an imaging system, an infusion pump and an anesthesia machine, the FDA said.