FDA Device recall Z-2483-2024
SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1
- FDA Device
- Class II
- ongoing
- Published 2024-08-14
On 2024-08-14 the FDA classified a Class II recall of SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1 by Ge Medical Systems, citing 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 fol….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2483-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-14 |
| Published | 2024-08-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems |
| Distribution | n/a |
Product
SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System
Reason
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.
Identifiers
| code_info | System ID: 319335MR1, A204479601, MR00026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2483-2024%22
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