GE Healthcare Recalls Centricity Universal Viewer Software Due to Orientation Marker Errors
GE Healthcare is recalling specific versions of the Centricity Universal Viewer Zero Footprint Client because orientation markers may display incorrectly after image manipulation.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a software defect that could lead to misinterpretation of medical images, but no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity rating.
Plain-English summary
GE Healthcare, LLC is recalling the Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, for specific software versions including 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a, SP8.0.2, SP9, and SP9.0.1. The recall involves 508 units distributed worldwide.
The recall is due to two software issues affecting the display of orientation markers. In the first issue, when an image is flipped horizontally and vertically, the orientation markers appear correctly initially. However, after new image rendering occurs—such as scrolling, playing cine loops, maximizing viewports, or resizing the browser—the orientation markers can become incorrect, even though the image orientation itself is maintained. The second issue occurs when an image in a series is flipped and rotated; if the user navigates to another image with a different orientation, the orientation markers on the new image can display incorrectly.
Healthcare facilities using these specific software versions should contact GE Healthcare for instructions on how to resolve the issue. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 508
Distribution
Distribution scope not specified by the agency.
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