SIGNA Creator, SIGNA Explorer

• 2 recalls, same reason

  • Ongoing Z-1242-2025 FDA Class II ·initiated 31 Jan 2025
  • Ongoing Z-1239-2025 FDA Class II ·initiated 31 Jan 2025

  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.

• 5 recalls, same reason

  • Ongoing Z-2473-2024 FDA Class II ·initiated 14 Jun 2024
  • Ongoing Z-2475-2024 FDA Class II ·initiated 14 Jun 2024
  • Ongoing Z-2472-2024 FDA Class II ·initiated 14 Jun 2024
  • Ongoing Z-2470-2024 FDA Class II ·initiated 14 Jun 2024
  • Ongoing Z-2476-2024 FDA Class II ·initiated 14 Jun 2024

  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.

• 2 recalls, same reason

  • Ongoing Z-0596-2022 FDA Class II ·initiated 23 Dec 2021
  • Ongoing Z-0597-2022 FDA Class II ·initiated 23 Dec 2021

  The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

• 2 recalls, same reason

  • Ongoing Z-2058-2021 FDA Class II ·initiated 4 Jun 2021
  • Ongoing Z-2059-2021 FDA Class II ·initiated 4 Jun 2021

  GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

• • Terminated Z-0137-2022 FDA Class II ·initiated 26 Aug 2021

  Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

• • Terminated Z-3026-2017 FDA Class II ·initiated 11 May 2017

  Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

• • Terminated Z-2731-2016 FDA Class II ·initiated 31 Aug 2016

  GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.

510(k) Number

K143251 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5T Open recall

  Class II

  FDA 510(k) K132376 Active Cleared 15 Nov 2013

• Optima MR450W

  Class II

  FDA 510(k) K123522 Active Cleared 13 Mar 2013

• SIGNA Architect Open recall

  Class II

  CE/MDR FDA 510(k) K202966 Active Cleared 13 Nov 2020 +1authorizations

• SIGNA Hero Open recall

  Class II

  CE/MDR FDA 510(k) K213668 Active Cleared 20 Jan 2022

• Ready View

  Class II

  FDA 510(k) K110573 Active Cleared 3 May 2011

• SIGNA Premier Open recall

  Class II

  CE/MDR FDA 510(k) K193282 Active Cleared 10 Apr 2020

See all devices from Ge Healthcare (Ge Medical Systems, LLC) →