SIGNA Victor — Class II medical device recall Z-2480-2024
Ongoing recall by GE Medical Systems, LLC, reported 2024-08-14. GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B
| Recall number | Z-2480-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2024-06-14 |
| Classified | 2024-08-02 |
| Reported by FDA | 2024-08-14 |
| Quantity | 23 units |
| Reason classes | device malfunction |
Product
SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
Reason for recall
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
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-2480-2024. 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.