GE Signa 3.0T with Excite MR System

• • Ongoing Z-0614-2022 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.

• 3 recalls, same reason

  • Terminated Z-0112-2019 FDA Class II ·initiated 7 Jun 2018
  • Terminated Z-0111-2019 FDA Class II ·initiated 7 Jun 2018
  • Terminated Z-0110-2019 FDA Class II ·initiated 7 Jun 2018

  The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.

• • Terminated Z-0256-2016 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.

• • Terminated Z-2339-2015 FDA Class II ·initiated 10 Jul 2015

  A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped left-right with incorrect orientation annotation.

• • Terminated Z-1305-2015 FDA Class II ·initiated 9 Mar 2015

  GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.

• • Terminated Z-1035-2015 FDA Class I ·initiated 7 Jan 2015

  At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.

• • Terminated Z-1943-2013 FDA Class II ·initiated 21 Nov 2011

  Screen save images are included in wrong exam due to duplicate UID creation. This may cause a safety issue due to a potential patient data mismatch.While the issue has only been observed at one customer site on the Signa HDxT 1.5T system, internal investigation revealed that the issue also impacts multiple GE healthcare MR Systems.

• • Terminated Z-0815-2007 FDA Unclassified (pre-2012) ·initiated 1 Jun 2006

  To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included in the software.

510(k) Number

K040444 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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