FDA Device recall Z-0125-2013
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy select…
- FDA Device
- Class II
- terminated
- Published 2012-10-31
On 2012-10-31 the FDA classified a Class II recall of GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy select… by Ge Healthcare, citing GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0125-2013 |
| 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 Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 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.
Reason
GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size.
Identifiers
| code_info | 000000010005GS 000000010004GS 000000010009GS 000000010007GS 000000010006GS 000000010010GS 000000010001GS 0000000…000000010005GS 000000010004GS 000000010009GS 000000010007GS 000000010006GS 000000010010GS 000000010001GS 000000010002GS 000000010008GS 000000010003GS 00000L3A4391A7 00000L3A8D5CF0 |
|---|
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-0125-2013%22
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