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.
Published December 26, 2018 · Recall initiated: November 9, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Worldwide
- Lot
- 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-02025461 (01)00840682102988(10)6.0SP9.0.12093796001D 105412-2-Centricity Universal Viewer Zero Footprint / ZFP-01978386 (01)00840682102988(10)6.0SP92093796001D 3846-2-Centricity Universal Viewer Zero Footprint / ZFP-01613236 (01)00840682102988(10)6.0SP72093796001D 2317-3-Centricity Universal Viewer Zero Footprint / ZFP-00165279 (01)00840682102988(10)6.0SP7.0.22093796001D 2317-3-Centricity Universal Viewer Zero Footprint / ZFP-00165278 (01)00840682102988(10)6.0SP7.0.22093796001D 1202-8-Centricity Universal Viewer Zero Footprint / ZFP-00100999 (01)00840682102988(10)6.0SP7.0.22093796001D 3805-8-Centricity Universal Viewer Zero Footprint / ZFP-02098759 (01)00840682102988(10)6.0SP8.0.22093796001D 3805-8-Centricity Universal Viewer Zero Footprint / ZFP-02098758 (01)00840682102988(10)6.0SP8.0.22093796001D 3805-8-Centricity Universal Viewer Zero Footprint / ZFP-02098757 (01)00840682102988(10)6.0SP8.0.22093796001D 3805-8-Centricity Universal Viewer Zero Footprint / ZFP-02098755 (01)00840682102988(10)6.0SP8.0.22093796001D 101764-1-Centricity Universal Viewer Zero Footprint / ZFP-01432060 (01)00840682102988(10)6.0SP7.0.12093796001D 101764-1-Centricity Universal Viewer Zero Footprint / ZFP-01432060 (01)00840682102988(10)6.0SP7.0.12093796001D 101764-1-Centricity Universal Viewer Zero Footprint / ZFP-01432060 (01)00840682102988(10)6.0SP7.0.12093796001D 101764-1-Centricity Universal Viewer Zero Footprint / ZFP-01432060 (01)00840682102988(10)6.0SP72093796001D 101764-1-Centricity Universal Viewer Zero Footprint / ZFP-01432060 (01)00840682102988(10)6.0SP72093796001D 101764-1-Centricity Universal Viewer Zero Footprint / ZFP-01432060 (01)00840682102988(10)6.0SP72093796001D 103944-3-Centricity Universal Viewer Zero Footprint / ZFP-01477454 (01)00840682102988(10)6.0SP8.0.22093796001D 10345-9-Centricity Universal Viewer Zero Footprint / ZFP-01425634 (01)00840682102988(10)6.0SP8.0.22093796001D 10345-9-Centricity Universal Viewer Zero Footprint / ZFP-01425634 (01)00840682102988(10)6.0SP8.0.22093796001D 10345-1-Centricity Universal Viewer Zero Footprint / ZFP-01419025 (01)00840682102988(10)6.0SP8.0.22093796001D 101349-2-Centricity Universal Viewer Zero Footprint / ZFP-00107435 (01)00840682102988(10)6.0SP7.0.22093796001D 101349-2-Centricity Universal Viewer Zero Footprint / ZFP-02098718 (01)00840682102988(10)6.0SP7.0.22093796001D 103944-3-Centricity Universal Viewer Zero Footprint / ZFP-01477454 (01)00840682102988(10)6.0SP9.0.12093796001D 13132-11-Cent
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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