GE Healthcare Recalls Centricity Universal Viewer Breast Imaging Software
GE Healthcare is recalling Centricity Universal Viewer Breast Imaging software because a display error could lead to incorrect patient diagnoses.
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 involves a risk-of-harm product where an incorrect diagnosis could occur, but the source text does not report any specific injuries or illnesses, fitting the High severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling Centricity Universal Viewer Breast Imaging software. The recall involves 297 units, with 131 located in the United States and 166 outside the US. The affected software includes versions 6.0 SP4 or higher with Breast Imaging integrated with either IDI Mammo Workstation version 4.7.x or any version of SenoIris.
The recall is due to a software defect where patient images displayed on high-resolution mammography monitors may not correspond to the patient selected in the Universal Viewer when users switch between multiple instances in the Windows taskbar. This discrepancy could result in an incorrect diagnosis.
The affected units were distributed worldwide, including in the United States and various international countries. Healthcare professionals using this software should contact GE Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Software
- Hazard
Distribution
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