GE Medical Systems, LLC Recall: SIGNA Explorer, with affected software versions: SV25.5, S
GE Medical Systems, LLC Recall: SIGNA Explorer, with affected software versions: SV25.5, S is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: GE Medical Systems, LLC; Product: SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonan
| Recalling firm | GE Medical Systems, LLC |
|---|---|
| Product | SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Worldwide distribution. |
| Recall initiated | 20240614 |
| Recall number | Z-2473-2024 |
| Category | device |
| State | WI |
| Country | United States |
$29/mo
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