Discovery MR450 The systems are whole body magnetic resonance… — Class II medical device recall Z-1188-2017
Terminated recall by GE Healthcare, LLC, reported 2017-02-22, distributed nationwide. Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event
| Recall number | Z-1188-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2017-01-20 |
| Classified | 2017-02-10 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2019-09-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, CZ, DE, DK, ES, FI, FR, GB, IT, NL, NO, PL, SA, SE, TW, UY |
| Quantity | 60 |
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.
Reason for recall
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.
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-1188-2017. 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.