Class II — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. If this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn. |
| Product | Discovery MR450 The systems are whole body magnetic resonance scanners 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. |
| Quantity | 60 |
| Distribution | Worldwide Distribution- US (nationwide) including states of: CA, DC, IL, MN, MO, NY, SC, TX, WI, WV; and countries of: Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and Uruguay. |
| Initiated | 2017-01-20 |
| Classified | 2017-02-10 |
| Terminated | 2019-09-24 |
| Recall number | Z-1188-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare, LLC (Z-1188-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76378/
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