Class 1 Recall: Cybersecurity Vulnerabilities of Hospira Symbiq Infusion System

Date Issued: July 31, 2015

Audience: Health care facilities using the Hospira Symbiq Infusion System

Device: Symbiq Infusion System, Version 3.13 and prior versions

The Hospira Symbiq Infusion System is a computerized pump designed for the continuous delivery of general infusion therapy for a broad patient population.

It is primarily used in hospitals, or other acute and non-acute health care facilities, such as nursing homes and outpatient care centers. This infusion system can communicate with a Hospital Information System (HIS) via a wired or wireless connection over facility network infrastructures.

Purpose:

The FDA is alerting users of the Hospira Symbiq Infusion System to cybersecurity vulnerabilities with this infusion pump. We strongly encourage that health care facilities transition to alternative infusion systems, and discontinue use of these pumps.

Summary of Problem and Scope:

The FDA, the U.S. Department of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team (ICS-CERT), and Hospira are aware of cybersecurity vulnerabilities associated with the Symbiq Infusion System.

Hospira and an independent researcher confirmed that Hospira’s Symbiq Infusion System could be accessed remotely through a hospital’s network. This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies. The FDA and Hospira are currently not aware of any patient adverse events or unauthorized access of a Symbiq Infusion System in a health care setting.

Hospira has discontinued the manufacture and distribution of the Symbiq Infusion System, due to unrelated issues, and is working with customers to transition to alternative systems. However, due to recent cybersecurity concerns, the FDA strongly encourages health care facilities to begin transitioning to alternative infusion systems as soon as possible.

Recommendations for Health Care Facilities:

While transitioning to an alternative infusion system, consider taking the following steps to reduce the risk of unauthorized system access:

• Disconnect the affected product from the network.
  
  CAUTION: Disconnecting the affected product from the network will have operational impacts. Disconnecting the device will require drug libraries to be updated manually. Manual updates to each pump can be labor intensive and prone to entry error.
• Ensure that unused ports are closed, including Port 20/FTP and Port 23/TELNET.
• Monitor and log all network traffic attempting to reach the affected product via Port 20/FTP, Port 23/TELNET and Port 8443. Contact Hospira’s technical support to change the default password used to access Port 8443 or close it.

While these infusion pumps are currently not available for purchase through Hospira, the FDA is aware that the Symbiq Infusion System is potentially available for purchase from third parties not associated with Hospira. The FDA strongly discourages the purchase of the Symbiq Infusion System from these parties. The FDA recommends health care facilities follow the good cybersecurity hygiene practices outlined in the FDA Safety CommunicationCybersecurity for Medical Devices and Hospital Networks, posted in June 2013.

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