Brivo MR355 — Class II medical device recall Z-3021-2017
Terminated recall by GE Medical Systems, LLC, reported 2017-08-23, distributed nationwide. Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock haz
| Recall number | Z-3021-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2017-05-11 |
| Classified | 2017-08-11 |
| Reported by FDA | 2017-08-23 |
| Terminated | 2020-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 68 units |
| UPC / GTIN / UDI-DI | 00840682103817, 00840682105378, 00840682105699, 00840682115872, 00840682115971 |
Product
Brivo MR355, Optima MR360 Product Usage: The 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.
Reason for recall
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3021-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.