FDA Device recall Z-0935-2013
Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System
- FDA Device
- Class II
- terminated
- Published 2013-03-20
On 2013-03-20 the FDA classified a Class II recall of Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System by Ge Healthcare, citing an error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0935-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-05-10 |
| Published | 2013-03-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.
Reason
An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.
Identifiers
| code_info | Serial Number 000000000R6708 00000241143MR7 00000027552MR4 00000028626MR7 00000028674MR1 00000262235MR5 00000272…Serial Number 000000000R6708 00000241143MR7 00000027552MR4 00000028626MR7 00000028674MR1 00000262235MR5 00000272922MR6 00000273268MR3 00000273598MR3 00000273631MR2 00000273632MR0 00000274287MR2 00000274288MR0 00000274740MR0 00000274742MR6 00000274886MR1 00000274887MR9 00000275000MR8 00000275001MR6 00000275003MR2 00000275463MR8 00000275464MR6 00000275527MR0 00000275528MR8 00000275533MR8 00000275534MR6 00000275535MR3 00000275536MR1 00000275537MR9 00000275538MR7 00000275539MR5 00000276137MR7 00000276164MR1 00000276184MR9 00000276196MR3 00000276197MR1 00000276241MR7 00000276242MR5 00000276243MR3 00000276244MR1 00000276245MR8 00000276457MR9 00000276458MR7 00000276461MR1 00000276637MR6 00000276656MR6 00000276657MR4 00000276658MR2 00000276659MR0 00000276660MR8 00000276676MR4 00000276678MR0 00000276680MR6 00000277441MR2 00000277442MR0 00000277443MR8 00000277444MR6 00000277531MR0 00000277533MR6 00000277534MR4 00000277535MR1 000002776 |
|---|
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-0935-2013%22
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