Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5T

• • Ongoing Z-2302-2025 FDA Class II ·initiated 20 Jun 2025

  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.

• • Ongoing Z-2468-2024 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.

• 4 recalls, same reason

  • Ongoing Z-0593-2022 FDA Class II ·initiated 23 Dec 2021
  • Ongoing Z-0602-2022 FDA Class II ·initiated 23 Dec 2021
  • Ongoing Z-0594-2022 FDA Class II ·initiated 23 Dec 2021
  • Ongoing Z-0601-2022 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.

• 4 recalls, same reason

  • Terminated Z-3023-2017 FDA Class II ·initiated 11 May 2017
  • Terminated Z-3022-2017 FDA Class II ·initiated 11 May 2017
  • Terminated Z-3024-2017 FDA Class II ·initiated 11 May 2017
  • Terminated Z-3025-2017 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-1188-2017 FDA Class II ·initiated 20 Jan 2017

  Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. If this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn.

• • Terminated Z-2131-2016 FDA Class II ·initiated 8 Jun 2016

  GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. No injury has been reported to GE as a result of this issue.

• • Terminated Z-0201-2019 FDA Class II ·initiated 7 Dec 2015

  GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue. UPDATE 5/27/2016: Recall has been updated to include an additional product which includes the Discovery 3.0T MR750 systems running Application Software DV24 R01, DV25 R02, or DV25.1 M3.

• 2 recalls, same reason

  • Terminated Z-0254-2016 FDA Class II ·initiated 31 Aug 2015
  • Terminated Z-0259-2016 FDA Class II ·initiated 31 Aug 2015

  When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.

510(k) Number

K132376 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• SIGNA Creator, SIGNA Explorer Open recall

  Class II

  FDA 510(k) K143251 Active Cleared 4 Feb 2015

• 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) →