SIGNA Architect system Product Usage: The Signa Architect system is a… — Class II medical device recall Z-0236-2019
Terminated recall by GE Medical Systems, LLC, reported 2018-10-31, distributed nationwide. A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a
| Recall number | Z-0236-2019 |
|---|---|
| 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 | 2018-10-03 |
| Classified | 2018-10-23 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2022-05-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR, KR, SE |
| Quantity | 4 units |
| Serial numbers | U30RF0251B, U30RF0258B, U30RF0268B, U30RF0275B |
| Model numbers | 5388807-100 |
Product
SIGNA Architect system Product Usage: The Signa Architect system 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 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
A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.
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-0236-2019. 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.