GE Healthcare Recalls Centricity Universal Viewer 6.0 for Measurement Errors
GE Healthcare is recalling Centricity Universal Viewer 6.0 because incorrect measurements in DICOM files may lead to potential misdiagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of misdiagnosis, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 205 units of the Centricity Universal Viewer 6.0, a medical device used to display images and data from various imaging sources. The recall affects Model 2088026-9XX, Versions 6.0 SP10 or higher.
The recall is due to a defect where 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.
The affected devices were distributed nationwide and internationally to Mexico and 24 additional countries. Users should contact GE Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 205
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model 2088026-9XX Versions 6.0 SP10 or higher
Distribution
Distributed nationwide across the United States.
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