SIGNA Vibrant Nuclear Magnetic Resonance Imaging System — Class II medical device recall Z-0877-2020
Terminated recall by GE Healthcare, LLC, reported 2020-02-05, distributed nationwide. It was identified that due to a potential installation workflow issue, the MR system date could be set incorre
| Recall number | Z-0877-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-12-23 |
| Classified | 2020-01-28 |
| Reported by FDA | 2020-02-05 |
| Terminated | 2020-12-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH, CN, DE, ES, FR, GB, IN, IT, JP, NL, OM, SE, TR |
Product
SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Reason for recall
It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system s date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.
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-0877-2020. 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.