Z-2476-2024 Class II Ongoing
FDA device recall Z-2476-2024 was initiated by GE Medical Systems, LLC on Jun 14, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 81 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 14, 2024
- Initiation Date
- Jun 14, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81 units
Product Description
SIGNA MR360, with affected software versions: SV25.5, SV25.6; 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.
Distribution Pattern
Worldwide distribution.
Code Information
System ID: 082427110087, 082427230163, 082427160298, 082427070229, 082427100384, 082427100377, 082427120249, 082427080097, 082427130131, 082427100383, 082427100368, 082427160308, 082427120270, 082427120268, 082427150113, 082427150115, 082427010174, 082427120282, 082427120281, 082427120255, 082427120253, 082427090378, 82427120311, 082427200139, 082427250125, 082427140203, 082427210214, 082427140201, 082427090366, 082427150108, 082427160258, 082427120275, 082427190165, 082427220115, 082427220083, 082427300035, 082427210242, 082427130128, 082427030178, 082427110088, 82427160344, 082427190175, 082427130132, 082427120251, 082427120293, 082427120263, 082427120248, 082427120265, 082427200180, 082427200149, 082427020101, 082427030202, 082427060121, 082427140192, 082427100376, 082427230167, 082427230161, 082427250090, 082427140184, 082427100501, 082427100437, 082427160328, 82427120341, 082427120246, 082427120361, 082427120316, 082427200188, 082427200158, 082427070254, 082427070274, 082427140245, 082427170036, 082427210215, 082427190201, 082427150137, 082427240090, 082427310164, 082427010184, 082427010192, 082427010160, 082427010201
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2476-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026