s5i Imaging System (2018-11-08)

Starting date:

November 8, 2018

Posting date:

November 28, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68446

• Reason
• Affected products

Affected products

s5i Imaging System

Reason

Philips Volcano is initiating a voluntary field corrective action to address an interoperability issue that affects Volcano s5i, core and core mobile systems with version 2.5 FFR/iFR software connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS). Other Hemodynamic Systems which do not adhere to commonly used pressure calibration values (0 v @ 0mmhg and 1v @ 100 mmhg) may also be impacted.

The version 2.5 FFR/iFR software is designed to calibrate with the aortic output of the Hemodynamic Monitoring System (HMS). If the HMS adheres to commonly used pressure calibration values, then the interoperability issue will not have any impact. However, if the system does not adhere to commonly used values the interoperability issue will prevent calibration of the software with an impacted HMS.

In cases where the HMS does not adhere to commonly used values, the volcano pa (ao) and the HMS ao may be misaligned by up to +/- 5 mm hg. This discrepancy may lead to confusion. Philips has confirmed that the FFR/iFR normalization process ensures there is negligible impact to the FFR/iFR measurements.

Affected products