FDA Device recall Z-3027-2017
1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system is a…
- FDA Device
- Class II
- terminated
- Published 2017-08-23
On 2017-08-23 the FDA classified a Class II recall of 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system is a… by Ge Medical Systems, citing possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3027-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-11 |
| Published | 2017-08-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Medical Systems |
| Distribution | US |
Product
1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa¿ HDx MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa eHDx system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Reason
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Identifiers
| code_info | Medical Device Listing No. D117354, D295466, D182389, D102432, D206140, D230310, D269569, D102430, D140572, D188736, D…Medical Device Listing No. D117354, D295466, D182389, D102432, D206140, D230310, D269569, D102430, D140572, D188736, D102434, D234841, D196247, D134019, D236543, D006275, D159181, D288890, D229859; Model No. Eaton 9130, 5323286, 5396502-5, 5499460-3, 5499460-6, 5499460-9, 5741000-3, 00840682115971, 5396502-2, 5499460-2, 5741000-2, 00840682115872, 5373011-3, 5396469-3, 5481490-2, 5481500-7, 5499460-7, 5499460-10, 5741000, 00840682103817, 5323286-101, 2377062-61, 2395001, 2395001-2, 2395001-3, 2395001-4, 00840682105699, 840682105378 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3027-2017%22
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