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.
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled the Centricity Universal Viewer Zero Footprint Client software due to issues with orientation markers on medical images. The recall affects multiple software versions (6.0 SP7 through SP9.0.1) running on model 2090258-001. Two specific problems were identified: in some versions, orientation markers can display incorrectly after image rendering occurs due to scrolling, playing cinema mode, changing viewports, or resizing the browser; in other versions, orientation markers can become incorrect when navigating between images in a series that have been flipped and rotated. While the actual image orientation is maintained correctly, the visual markers indicating that orientation may not display properly, which could affect how users interpret medical images. Approximately 508 units worldwide have been distributed.
The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Issue #1 affects 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. When an image is flipped horizontally and vertically, the orientation markers appear correctly on the image to which they were applied. However, once new image rendering happens on this image or series (with scrolling; playing cin¿; maximizing or changing viewports/layouts; or synchronizing viewports and resizing the browser), the new image orientation is correctly maintained but the display of orientation markers can become incorrect. Issue #2 affects Software Versions 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. When an image in a series is flipped and then rotated in Zero Footprint Viewer (ZFP), the orientation markers appear correctly on the image to which they were applied. However, once you navigate to another image in the series and the image you navigated to has a different orientation than the prior image from which you navigated, the new image orientation is correctly maintained but the display of orientation markers can become incorrect.
Reason for recall: Issue #1 affects 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. When an image is flipped horizontally and vertically, the orientation markers appear correctly on the image to which they were applied. However, once new image rendering happens on this image or series (with scrolling; playing cin¿; maximizing or changing viewports/layouts; or synchronizing viewports and resizing the browser), the new image orientation is correctly maintained but the display of orientation markers can become incorrect. Issue #2 affects Software Versions 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. When an image in a series is flipped and then rotated in Zero Footprint Viewer (ZFP), the orientation markers appear correctly on the image to which they were applied. However, once you navigate to another image in the series and the image you navigated to has a different orientation than the prior image from which you navigated, the new image orientation is correctly maintained but the display of orientation markers can become incorrect. Distribution: Worldwide Quantity: 508 units Lot/code info: Serial Number UDI 4532-2-Centricity Universal Viewer Zero Footprint / ZFP-01889426 (01)00840682102988(10)6.0SP82093796001D 4532-2-Centricity Universal Viewer Zero Footprint / ZFP-01889426 (01)00840682102988(10)6.0SP82093796001D 10213-1-Centricity Universal Viewer Zero Footprint / ZFP-01815213 (01)00840682102988(10)6.0SP72093796001D 10711-1-Centricity Universal Viewer Zero Footprint / ZFP-01970566 (01)00840682102988(10)6.0SP72093796001D 100620-2-Centricity Universal Viewer Zero Footprint / ZFP-00099694 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-00105531 (01)00840682102988(10)6.0SP7.0.22093796001D 3730-1-Centricity Universal Viewer Zero Footprint / ZFP-01803680 (01)00840682102988(10)6.0SP7.0.22093796001D 3730-1-Centricity Universal Viewer Zero Footprint / ZFP-01803680 (01)00840682102988(10)6.0SP7.0.22093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-00102068 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-00105530 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-00105531 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-00105531 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-02025410 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-0202546
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.