SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- GE Medical Systems, LLC
- 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 I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2476-2024
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