FDA Device recall Z-2241-2013
GE Healthcare, Advantage Workstation, READY View Application
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of GE Healthcare, Advantage Workstation, READY View Application by Ge Healthcare, citing GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2241-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-03-27 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | IL, MN, NJ, NY, VA |
Product
GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
Reason
GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.
Identifiers
| code_info | Mfg Lot or Serial # 00000235940GE4 00000260698GE6 00000260686GE1 00000235943GE8 00000253548GE2 00000260699GE4 00…Mfg Lot or Serial # 00000235940GE4 00000260698GE6 00000260686GE1 00000235943GE8 00000253548GE2 00000260699GE4 000000010006GS 00000L3AB501ED 00000253550GE8 00000253551GE6 00000260681GE2 00000260682GE0 00000260683GE8 00000260684GE6 00000260685GE3 00000260687GE9 00000260688GE7 00000260689GE5 00000260690GE3 00000260691GE1 00000260692GE9 00000260693GE7 00000260694GE5 00000260695GE2 00000260696GE0 00000260697GE8 00000253549GE0 00000235942GE0 0000AQ11258001 000000010005GS 0000CZC1337NYP 00000Q11076015 0000AV11249006 0000AQ11265005 0000AQ11265003 000D1L3AAF7CD2 00000L3AB68D60 00000L3A2BABE7 00000L3AAFB343 00000235941GE2 000000010022GS 00000222344GE4 00000253546GE6 000000010013GS 00000L6B045EFC 000000010012GS 00000L3A330899 00000LFB4460DC 0000AJ11175002 0000AJ11175001 00000E11248004 00000E11248003 00000W11292005 00000W11292006 00000W11292007 00000W11292008 0000AC11273001 0000AC11273002 0000AA11187002 0000AA11187003 0000AA11187004 000 |
|---|
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-2241-2013%22
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