The FDA announced on 2019-12-16 that GE Healthcare LLC voluntarily recalled the Centricity Universal Viewer 6.0 device due to measurement errors that may lead to misdiagnosis. The agency's recall number is Z-0819-2020.
How to tell if you have it
- Brand: GE Healthcare
- Product: Centricity Universal Viewer 6.0
- Model: 2088026-9XX
- Versions: 6.0 SP10 or higher
The hazard
According to the FDA, measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes. This error may lead to a potential misdiagnosis.
Context
GovInfoNow's records show GE Healthcare LLC has 97 other recalls on record since 2017-10-04. Other recent recalls of similar products include GE Healthcare SIGNA Premier MRI Scanners May Have Steel Fittings Risking Injury (2026-02-27), GE Centricity Universal Viewer 6.0/7.0/8.0: Inaccurate Distance Measurements (2022-07-15), and GE Healthcare SIGNA Premier MRI Scanner Recall: Risk of Hearing Loss from Acoustic Noise (2022-06-24). Additional similar recalls include GE Healthcare Centricity Universal Viewer Zero Footprint Client Recall: Patient Info Mismatch Risk (2026-01-16), GE Healthcare Centricity PACS Server V7 Recall: Risk of Wrong Patient Images (2026-07-31), and GE Healthcare Centricity PACS Software Recall: Patient Data Mismatch Risk (2026-07-31).