Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:14656
Brand Name:GE Signa Magnetic Resonance Imaging System
Model:Models: 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant
Affected:PACS systems manufactured by Intelerad (IntelePACS 4-3-1-P350 and InteleBrowser -4-3-1-P350)
Software version:
Recalling Organisation:GE Healthcare Limited
Level 7, Vero Centre
48 Shortland St
Auckland 1010
Contact Information:0800 659 465
Manufacturer:GE Medical Systems LLC
Issue:For ClariView and Screen Save from GVTK (Gems Visualization ToolKit) Viewer, the MR Product can generate image headers with non-unique series identifiers, which when exported to some PACS systems, results in the series being associated with the incorrect study on the PACS. The intended study will not have the correct series listed and an unintended study will have it listed instead. In all cases, patient identifying annotation remains correct.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:16/5/2013
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