For U.S. healthcare professionals only.

INFORMATION TECHNOLOGY ADVISORY

SweynTooth Cybersecurity Vulnerabilities

March 10, 2020

The U.S. Food and Drug Administration (FDA) recently notified the healthcare community about the SweynTooth family of cybersecurity vulnerabilities, which are associated with Bluetooth Low Energy wireless communication technology and have the potential to impact medical devices.

To read the full notification, please visit the FDA press announcement web page and select the below titled article from March 3, 2020:

FDA Informs Patients, Providers and Manufacturers About Potential Cybersecurity Vulnerabilities in Certain Medical Devices with Bluetooth Low Energy

Given this announcement, we want to assure you that Bayer injection systems do not utilize Bluetooth. Therefore, the SweynTooth vulnerabilities do not pose a threat to any fielded Bayer injection system.


 

Important Update - AVG AntiVirus Software used with Bayer devices operating on Microsoft® Windows 7

The purpose of this message is to provide you with an update on the Microsoft® Windows 7 to Windows 10 transition plan for your Bayer device.

As previously communicated, although Microsoft will support Windows Embedded Standard 7 Service Pack 1 through October 13, 2020, the current AVG AntiVirus software protection on Bayer devices running this version of Windows 7 will expire on January 31, 2020.

The Bayer Service team has been working to transition customers to Windows 10 in advance of the Windows Embedded Standard 7 Service Pack 1 end of support date to ensure that all compatible fielded devices receive ongoing security updates and antivirus protection. As a reminder, any Bayer device running Windows 7 is operating on Windows Embedded Standard Service Pack 1.

In the interim, to ensure that customer devices running Windows 7 do not experience a lapse in antivirus coverage, Bayer will take the following immediate actions:

Customers with a Certegra® Workstation or VirtualCARE™ Box operating on Windows 7 and actively connected to VirtualCARE™ Remote Support

Virtual Updates:

  • Beginning the week of January 20, 2020, Bayer will remotely deliver a security update to all customers with Windows 7 to extend AVG antivirus protection for one year. This update will occur virtually, and customers will not notice any changes to their operating system, nor will they be required to reboot their Bayer device. The security update will not impact or disrupt any patient procedures.
  • This update doesn’t impact the Windows 10 migration, which will still occur before October 2020. This extended protection will ensure the continued functionality of the AVG software until product software on the device is updated to Windows 10.

Customers with a Certegra® Workstation or VirtualCARE™ Box operating on Windows 7 and not actively connected to VirtualCARE™ Remote Support

  • As previously communicated, a Bayer Service representative will contact you to migrate your system to Windows 10 before October 13, 2020.
  • If your Workstation isn’t connected to VirtualCARE™ Remote Support but is connected to your hospital network, please contact Bayer Service for an assessment of next steps related to the migration.
  • If you have any other questions or concerns regarding the upgrade or your AVG software, please contact the Bayer Service at 1-877-229-3767.

Certegra® Box

  • As previously communicated, the Certegra® box (legacy hardware used to enable informatics connectivity prior to the release of the Certegra® Workstation) reached its end of life on January 1, 2020. End of life means that Bayer will no longer offer service or support, including antivirus updates, on the installed base of Certegra® Boxes in the US.

Windows 10 Migration

Bayer remains committed to installing Microsoft® Windows 10 on all compatible fielded devices, which will provide customers with antivirus protection through Microsoft Windows Defender. The Microsoft Windows migration applies to all customers. The transition will happen either through a product software update or an equipment platform upgrade.

For more information regarding the transition to Windows 10 for Bayer devices, please refer to the Information Technology Advisory from October 29, 2019 below.


 

Urgent/11 Vulnerability

November 22, 2019

Bayer has performed an assessment of the recently announced URGENT/11 vulnerability, which affects VxWorks. VxWorks is the most widely used real-time operating system(RTOS) in the world, and Bayer uses it in some of our devices. The vulnerability resides in the VxWorks TCP/IP stack(IPnet), impacting all versions since version 6.5.

Based on our analysis, we have determined that no Bayer devices are affected by the URGENT/11 vulnerability, due to the versions that we employ in our devices.

Product security and safety are of tremendous importance to Bayer, and we will continue to monitor the situation and the associated activity and provide updates, as needed.

 


 

Support for Microsoft® Windows 7 is ending – understand the transition plan for your Bayer device

October 29, 2019

Microsoft® has announced an important product lifecycle milestone for its Windows 7 Operating System, which may have an impact on your Bayer device.

In 2020, Microsoft will discontinue support of Windows 7, which means that it will no longer provide security updates, software updates or technical support for the Operating System.

 

How does this milestone impact your Bayer device?

Bayer has decided that in order to effectively support fielded devices while providing customers with the latest Microsoft Operating System, it will proactively migrate all compatible* Windows-based Bayer devices to Windows 10.

If your facility has a Bayer device in service that is operating on Windows 7 or Windows XP, Bayer has a plan to support your transition to Windows 10, whether through a product software update or an equipment platform upgrade.

 

What is the transition plan for your Bayer device?

If your facility has one or more of the devices below in service, it is likely running on Windows 7 or Windows XP. Please click on the product links below to understand the detailed transition plan for your device.

In addition, please be aware that due to the transition to Windows 10, the current antivirus protection on Bayer devices running Windows 7 and Windows XP will not be renewed beyond January 2020.

Don’t see your Bayer device on the list?

Some Bayer devices are already operating on Microsoft Windows 10 and others do not operate on a Microsoft Windows-based platform. Therefore, they are not affected by Windows 7 end of support:

  • MEDRAD® Stellant FLEX CT Injection System
  • Standalone MEDRAD® Stellant Classic, MEDRAD® Spectris Solaris EP, MEDRAD® Mark 7 Arterion and MEDRAD® Avanta Injection Systems
  • MEDRAD® EnVision, MEDRAD® Spectris and MEDRAD® Provis Injection Systems

 

Bayer is committed to helping your facility through the transition from Windows 7 to Windows 10. Please continue to visit Bayer in Radiology’s Information Technology Advisory web page to receive ongoing updates on the migration process or contact Bayer Service at 1-877-229-3767 for support.

 

*The Certegra Box is a legacy device that predates Bayer’s three generations of Certegra® Workstation technologies. As such, it is not compatible with Windows 10. Bayer offers several upgrade pathways to assist customers with the transition from the Certegra Box to the Certegra® Workstation 3.0. Please contact your local Bayer Sales Representative for more information.

† The MEDRAD® Intego 200 PET Infusion System does not utilize the same antivirus software as the MEDRAD® Stellant CT Injection System, the MEDRAD® MRXperion Injection System and the VirtualCARE™ Remote Support hardware. As such, the timeline for migration to Windows 10 for the Intego 200 product line is different. Please refer to the product links above for more information.  

 


 

Information on Orangeworm vulnerability

April 30, 2018

Bayer Radiology has performed an assessment of the below listed Orangeworm vulnerability, and, based on the current understanding and our internal research, we have determined that there is no immediate safety or security threat to Bayer Radiology medical devices, including MEDRAD® Stellant and MEDRAD® MRXperion control room units (Certegra® Workstations), Certegra® and VirtualCare™ devices, MEDRAD® Intego, and Certegra® Connect CT. This is due to the fact that the current primary attack vector is through phishing techniques, which are not supported on these Bayer Radiology medical devices. Bayer Radiology medical devices are not a primary entry point for a phishing-based attack such as Orangeworm, but are highly dependent on the strength of the network on which they are deployed. Bayer Radiology recommends regular network maintenance and patch updates to mitigate vulnerabilities, such as Orangeworm.

The Bayer Radiology Radimetrics™ Enterprise Platform is not impacted by this vulnerability, as it is a Linux-based system and does not rely on MS Windows.

We will continue to monitor the situation and the associated activity and provide updates as needed.

 

Potential Orangeworm vulnerability:

Trojan.Kwampirs

Trojan-type virus affecting MS Windows systems, which may open a back door on the compromised system and download potentially malicious files.

 


 

Information on Meltdown and Spectre security issue

January 15, 2018

Bayer Radiology is committed to product safety and security, and an integral element of the Bayer cyber response process is the ongoing global monitoring for cybersecurity signals. Bayer Radiology maintains a testing and monitoring infrastructure, complete with assessment and vulnerability analysis tools, that enables continuous awareness of industry threats. Currently, our Bayer Radiology CyberSecurity team is conducting risk and vulnerability assessments of the recently discovered Meltdown and Spectre vulnerabilities in order to determine potential impact on Bayer Radiology products.

Bayer Radiology will continue to monitor activity and updates associated with the Meltdown and Spectre vulnerabilities, including mitigation solutions being released by various entities. Bayer will continue to post updates regarding this security issue on this website. Customers
requiring further assistance should call Bayer at 1-877-229-3767.