Health product recall

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

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

Centricity Universal Viewer

Lot or serial number

Not applicable

Model or catalog number

2088034-X

Companies
Manufacturer

GE Healthcare

500 W Monroe Street

Chicago

60661

Illinois

UNITED STATES