CLASS II Device recall · Reported 23 Aug 2017 · FDA Enforcement Report
Signa Creator, Signa ExplorerProduct Usage recalled
GE Medical Systems is recalling Signa Creator, Signa ExplorerProduct Usage: 5T Signa Creator and 5T Signa Explorer is a, distributed nationwide in the US. The recall was initiated on 11 May 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3026-2017
- FDA event ID
- 77488
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 May 2017
- FDA classified
- 11 Aug 2017
- Reported
- 23 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 11 May 2017 | Recall initiated by company | |
| 11 Aug 2017 | Classified by FDA | +92 days |
| 23 Aug 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Product as listed by the FDA
SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions 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. Depending on the region of interest being imaged, contrast agents may be used. The images produced by 1.5T SIGNA Creator and 1.5T SIGNA Explorer reflects the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Where it was distributed
US Nationwide in the states of : AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI
Nationwide AlaskaCaliforniaColoradoConnecticutDelawareFloridaIowaIllinoisIndianaKansasKentuckyLouisianaMarylandMissouriNorth DakotaNebraskaNew JerseyNew YorkOhioPennsylvania
Questions about this recall
Is Signa Creator, Signa ExplorerProduct Usage: 5T Signa Creator and 5T Signa Explorer is a recalled?
Yes. GE Medical Systems recalled Signa Creator, Signa ExplorerProduct Usage: 5T Signa Creator and 5T Signa Explorer is a on 11 May 2017. The recall is Class II and its status is Terminated. Recall number Z-3026-2017.
Why was it recalled?
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Which lots are affected?
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
Where was it sold?
US Nationwide in the states of : AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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