FDA Device recall Z-1137-2013
GE Healthcare, AW Server
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of GE Healthcare, AW Server by Ge Healthcare, citing GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1137-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-28 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
Reason
GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occasional basis, when multiple users are simultaneously accessing the Results Viewe
Identifiers
| code_info | Mfg Lot or Serial # 00000267104GE8 00000276601GE2 00000211976GE6 00000223238GE7 00000257702GE1 00000183554HP5 00…Mfg Lot or Serial # 00000267104GE8 00000276601GE2 00000211976GE6 00000223238GE7 00000257702GE1 00000183554HP5 00000248244GE6 000001010056GS 00000256021GE7 00000240706GE2 00000223235GE3 00000218205GE3 00000216337GE6 00000266111GE4 00000223234GE6 00000276603GE8 00000275004GE0 00000183573HP5 00000183555HP2 00000235884GE4 00000240705GE4 00000222533GE2 00000218207GE9 00000257708GE8 00000275003GE2 00000261642GE3 00000214206GE5 00000214821GE1 00000266112GE2 00000217429GE0 00000240703GE9 00000257707GE0 00000219371GE2 00000235886GE9 00000217427GE4 00000216338GE4 00000183518HP0 00000271798GE1 00000214817GE9 00000216334GE3 00000235885GE1 00000183570HP1 00000216331GE9 00000183568HP5 00000267105GE5 00000217428GE2 00000211978GE2 000001010012GS 00000240704GE7 00000229339GE7 00000216340GE0 00000266110GE6 00000267106GE3 00000260456GE9 00000222536GE5 00000261644GE9 00000214818GE7 00000183562HP8 00000229342GE1 00000276070GE0 00000235883GE6 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-1137-2013%22
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