FDA Device recall Z-2257-2013
GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 53…
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 53… by Ge Healthcare, citing GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2257-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-20 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. 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 recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety.
Identifiers
| code_info | Seno Advantage Workstations with RIS CCOW integration: Patient mismatch while receiving images - FMI 12187 Serial #…Seno Advantage Workstations with RIS CCOW integration: Patient mismatch while receiving images - FMI 12187 Serial # 00000179275GE3 00000136608GE7 00000136609GE5 00000123803GE9 00000206492GE1 00000179274GE6 00000179273GE8 00000179272GE0 00000177331GE6 00000128528GE7 00000132314GE6 00000106422GE9 00000188371GE9 00000179281GE1 00000179282GE9 00000106426GE0 00000106427GE8 00000250274GE8 00000142837GE4 00000142836GE6 000000010001GS 00000114907GE9 00000158810GE2 00000084251GE8 00000112122GE7 00000123807GE0 000000310001GS 000000010008GS 000000010007GS 00000106420GE3 00000114906GE1 00000250277GE1 00000165231GE2 00000136610GE3 00000114088GE8 00000114089GE6 00000112926GE1 00000206490GE5 00000154938GE5 00000190211HP3 00000174027GE3 00000174026GE5 00000190278HP2 000000010004GS 00000164500GE1 00000158809GE4 00000158410GE1 00000165228GE8 00000165229GE6 00000123804GE7 00000166277GE4 00000114091GE2 00000106425GE2 00000106424GE5 00000179280GE3 0 |
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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-2257-2013%22
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