GE Healthcare, LLC: Medical Device Recall in 2020 - (Recall #: Z-0819-2020)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2020.
Data Source: FDA.
Product Description:
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Product Classification:
Class II
Date Initiated: December 16, 2019
Date Posted: January 29, 2020
Recall Number: Z-0819-2020
Event ID: 84584
Reason for Recall:
Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis.
Status: Terminated
Product Quantity: 205
Code Information:
Model 2088026-9XX Versions 6.0 SP10 or higher
Distribution Pattern:
Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.
Voluntary or Mandated:
Voluntary: Firm initiated