Reported Aug 23, 2017 · Terminated
Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner…
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3200 N Grandview Blvd · Waukesha, WI · 53188-1693
Is this the product you have?
- Brivo MR355
- Optima MR360 Product UsageThe Brivo MR355/Optima MR360 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 the Brivo MR355/Optima MR360 reflect 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
- Lot codes and dates
Medical Device Listing No. D117354D295466D182389D102432D206140D230310D269569D102430D140572D188736D102434D234841D196247D134019D236543D006275D159181D288890D229859Model No. Eaton 913053232865396502-55499460-35499460-65499460-95741000-3008406821159715396502-25499460-25741000-2008406821158725373011-35396469-35481490-25481500-75499460-75499460-105741000008406821038175323286-1012377062-6123950012395001-22395001-32395001-400840682105699840682105378
- Amount recalled
- 68 units in total
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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