GE Healthcare, LLC Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
Model 2088026-9XX Versions 6.0 SP10 or higher
Products Sold
Model 2088026-9XX Versions 6.0 SP10 or higher
GE Healthcare, LLC is recalling Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging due to Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm initiated their correction on 12/16/2019 by letter. The letter explained the issue and directed the consignee to follow instructions in the letter until an update to the Centricity Universal Viewer can be made by the firm to correct the issue.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026