Recall Z-0819-2020— GE Healthcare, LLC

Name: FDA recall Z-0819-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-16

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-12-16, terminated 2023-10-05. It names 2 FDA 510(k) clearances: K182419, K150420. Product: Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.. Reason: 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-12-16
Terminated: 2023-10-05
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K182419 — Centricity Universal ViewerGE Healthcare·cleared 2018-12-14
K150420 — Centricity Universal ViewerGE Healthcare·cleared 2015-05-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.