NA SIGNA Explorer (UDI 00840682113762)Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

13 other recalls cover devices cleared under the same FDA submission (K143251); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 31, 2025Open, Classified

   For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.

   Z-1241-2025 · Root cause: Software design · FDA record ↗

2. Jan 31, 2025Open, Classified

   For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.

   Z-1239-2025 · Root cause: Software design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143251. One submission often covers many models, so check the product and lot details in each record.

• Z-1242-2025 · Jan 31, 2025 · Open, Classified
  SIGNA MR355, SIGNA MR360, NMRI system
• Z-2470-2024 · Jun 14, 2024 · Open, Classified
  SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
• Z-2475-2024 · Jun 14, 2024 · Open, Classified
  SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
• Z-2476-2024 · Jun 14, 2024 · Open, Classified
  SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
• Z-2472-2024 · Jun 14, 2024 · Open, Classified
  SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
• Z-2473-2024 · Jun 14, 2024 · Open, Classified
  SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
• Z-0596-2022 · Dec 23, 2021 · Open, Classified
  GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance imaging system.
• Z-0597-2022 · Dec 23, 2021 · Open, Classified
  GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.
• Z-0137-2022 · Aug 26, 2021 · Terminated
  SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
• Z-2058-2021 · Jun 4, 2021 · Open, Classified
  SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
• Z-2059-2021 · Jun 4, 2021 · Open, Classified
  SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System
• Z-3026-2017 · May 11, 2017 · Terminated
  SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-t
• Z-2731-2016 · Aug 31, 2016 · Terminated
  GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.