FDA Device recall Z-0095-2013
GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is…
- FDA Device
- Class II
- terminated
- Published 2012-10-31
On 2012-10-31 the FDA classified a Class II recall of GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is… by Ge Healthcare, citing GE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno Advantage Workstation that may imp….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0095-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-24 |
| Published | 2012-10-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.
Reason
GE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno Advantage Workstation that may impact patient safety. The measurement values provided by the Seno Advantage Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiv
Identifiers
| code_info | Mfg Lot or Serial # SA2 000000410032GS 000000410033GS 000000410027GS 000000410047GS 000000410041GS 000000410051GS…Mfg Lot or Serial # SA2 000000410032GS 000000410033GS 000000410027GS 000000410047GS 000000410041GS 000000410051GS 000000410087GS 000000410065GS 000000410031GS 000000410035GS 000000410136GS 000000410064GS 000000410037GS 000000410030GS 000000410049GS 000000410028GS 000000410113GS 000000410069GS 000000410052GS 000000410056GS 000000410043GS 000000410044GS 000000410048GS 000000410038GS 000000410042GS 000000410101GS 000000410036GS 000000410039GS 000000410073GS 000000410054GS 000000410134GS 000000410062GS 000000410112GS 000000410045GS 000000410063GS 000000410060GS 000000410034GS 000000410072GS 000000410057GS 000000410061GS 000000410058GS 000000410050GS 000000410071GS 000000410059GS 000000410055GS 000000410070GS 000000410053GS 000000410029GS 000000410067GS 000000410068GS 000000410066GS 000000410133GS 000000410011GS 000000410010GS 000000410009GS 000000410007GS 000000410006GS 000000410008GS 000000410096GS 000000410089GS 000000410090GS |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0095-2013%22
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