Centricity Universal Viewer (2018-12-27)

Starting date:

December 27, 2018

Posting date:

January 23, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68846

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  Reason
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  Affected products

Affected products

Centricity Universal Viewer

Reason

Specific workflows of the Centricity Universal Viewer (UV) workstation can cause a loss of synchronization in the patient context between UV and either SenoIris or IDI Mammo workstation. In a pacs-driven workflow (UV study list), where universal viewer is integrated with senoiris or IDI Mammo workstation, the following could occur:

When switching back and forth between multiple universal viewer instances in the windows taskbar, the patient images displayed on the Mammo high resolution monitors may not show images of the patient selected on universal viewer, which could result in an incorrect diagnosis. All images display the correct patient name.

This issue affects centricity universal viewer version 6.0 SP4 or higher breast imaging integrated with either IDI Mammo workstation version 4.7.x or all versions of SenoIris.

Affected products