SIGNA Hero

Evidence summary

The K213668 FDA decision summary describes SIGNA Hero modifications, AIR Recon DL and workflow changes, unchanged indications, DICOM and system functions, and sample clinical-image evaluation supporting substantial equivalence. It does not establish a general clinical sensitivity or specificity claim for the scanner or reconstruction.

• FDA source
• Exact FDA submission
• Checked 2026-09-03

• Source

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Postmarket safety review

2 exact-submission FDA recall records in the 2026-09-02 openFDA snapshot identify K213668. Affected model, version, unit, correction, and current manufacturer instructions still require local confirmation. FDA recall Z-2308-2025 is Open, Classified for GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System. FDA reason: GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. FDA action: GE HealthCare issued an URGENT CORRECTION NOTICE to it consignees on 06/20/2025 via traceable means. The notice explained the safety issue and requested the following actions be taken: "You can continue to use your MR system by following the instructions below: In the undocked position, lock the table by pressing the pedal in the front of the table. Check to see that all casters are locked and that the table is secure. Contact your GE HealthCare representative for assistance if any of the casters do not lock. Before each patient transfer verify that the caster locks are engaged. If you notice more than one caster is damaged or fails to lock properly, use particular caution as the table may move while in use. No additional steps are required to continue to use your table in the docked position. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." "GE HealthCare will inspect and if necessary, correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction." " if you have any questions for concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative." FDA recall Z-2461-2024 is Open, Classified for SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System. FDA 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. FDA action: GE Healthcare issue an URGENT MEDICAL DEVICE CORRECTION to its consignees via letter on 06/14/2024. The letter explained the problem with the device, safety issue, and requested the following: "Actions to be taken by Customer/User: You can continue to use your MR system by following the instructions below: To ensure that the displayed B1+RMS value on the Scan Prescription User Interface does not exceed the user prescribed limit specified in the Low SAR Mode User Interface: " If your software version includes the Optimized T2 FLAIR Sequence option, enable this option by setting the value to 1.00. This option is present on the Advanced Tab of the Scan Prescription User Interface. " If your software version does not include the Optimized T2 FLAIR Sequence option, adjust scan parameters such as TR , # Slices or Auto Refocus Flip Angle until the displayed B1+RMS value on the Scan Prescription User Interface does not exceed the user prescribed limit. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

• FDA source
• Exact FDA submission
• Checked 2026-09-04

Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.

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• Source
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• Verify security and privacy controls: Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
• Verify pricing and total cost: No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA decision materials were reviewed for identity, indication, users, workflow, limitations, and submitted performance. Current vendor material is labeled product-family context where it does not establish the exact release. PubMed and ClinicalTrials.gov results are retained as candidate evidence with version applicability pending; CMS reimbursement context and exact-identifier openFDA postmarket results were also checked. Pricing, final security architecture, contracted services, enabled options, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. 2 FDA recall candidates were manually reviewed: 2 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 2 postmarket candidate records; 2 have been reviewed (2 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall