S5I IMAGING SYSTEM and VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT (2017-11-17)

Starting date:

November 17, 2017

Posting date:

December 8, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-65348

• 
  Reason
• 
  Affected products

Affected products

A. S5I IMAGING SYSTEM

B. VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT

Reason

Philips Volcano is initiating a voluntary correction to address a configuration issue that affects some s5i and

CORE Mobile systems with software version v3.5 (“Impacted Systems”). On certain Impacted Systems, an

unexpected Microsoft Windows Security dialog may appear during use, and the user’s response to the dialog

may adversely affect the subsequent operation of the device.

The Microsoft Windows security settings on a small number of Impacted Systems were incorrectly configured

during the manufacturing process. This misconfiguration can lead to a Windows Security Alert dialog being

displayed when the system is switched from IVUS to the FFR/iFR mode. If the user responds to the dialog by

selecting “Allow Access,” the device’s network firewall settings will be modified, opening its network ports to

potential unexpected communication from the hospital network to which the device is connected.

Unexpected communication from the hospital network could include normal network security operations, e.g.,

port scanning. If these communications occur during an active FFR/iFR procedure, data recording could be

affected leading to:

• Incorrect FFR/iFR measurements
• Case delay during troubleshooting and/or port scanning
• Abandonment of use of the system

Based on our investigation there is only a remote probability that any of these impacts may occur.

A correction has been identified and put in place on the manufacturing line to prevent further occurrences of this

issue for newly manufactured systems. Based on analysis of the frequency of occurrence on the manufacturing

line, it is expected that approximately 10% of the systems running v3.5 were are potentially misconfigured.

However as this installation configuration was not recorded during the manufacturing of the device, it is unknown

which serial numbers will exhibit the Windows Security Dialog.

Affected products