Achieva R4 1.5T and Achieva R4 3.0T

• • Ongoing Z-3314-2026 FDA Class II ·initiated 28 Aug 2026

  When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.

• • Ongoing Z-3243-2026 FDA Class II ·initiated 21 Aug 2026

  A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

• • Completed Z-2411-2021 FDA Class II ·initiated 11 Aug 2021

  When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

• • Terminated Z-2346-2021 FDA Class II ·initiated 30 Jul 2021

  Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

• 3 recalls, same reason

  • Terminated Z-0924-2019 FDA Class II ·initiated 21 Dec 2018
  • Terminated Z-0925-2019 FDA Class II ·initiated 21 Dec 2018
  • Terminated Z-0926-2019 FDA Class II ·initiated 21 Dec 2018

  There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

• • Terminated Z-0825-2017 FDA Class II ·initiated 1 Dec 2016

  Possibility that a patient or user may be exposed to a very small level of touch current.

• • Terminated Z-0325-2016 FDA Class II ·initiated 21 Aug 2014

  When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultant image order is reversed. This occurs with software release R5.1.7/R5.1.8.

• • Terminated Z-2237-2014 FDA Class II ·initiated 27 Jul 2014 ·on shared 510(k) K110151

  The following software issues have been identified in the affected products. Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac Application, the ejection fraction (EF) displayed should be the same as the ejection fraction (EF) originally displayed when the bookmark was first created. In some instances, the ejection fraction (

• 4 recalls, same reason

  • Terminated Z-1864-2014 FDA Class II ·initiated 13 Jun 2014
  • Terminated Z-1865-2014 FDA Class II ·initiated 13 Jun 2014
  • Terminated Z-1863-2014 FDA Class II ·initiated 13 Jun 2014
  • Terminated Z-1862-2014 FDA Class II ·initiated 13 Jun 2014

  For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

• 2 recalls, same reason

  • Terminated Z-1826-2014 FDA Class II ·initiated 15 May 2014
  • Terminated Z-1827-2014 FDA Class II ·initiated 15 May 2014

  Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.

• • Terminated Z-0135-2016 FDA Class II ·initiated 5 May 2014

  In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases, where MobiView fused Images are used to show the cross reference lines, the cross reference lines may be positioned incorrectly.

• • Terminated Z-1678-2014 FDA Class II ·initiated 11 Mar 2014 ·on shared 510(k) K110151

  During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is being applied in the AutoSPECT Pro application on IntelliSpace Portal. In addition, resolution recovery is not applied correctly in SPECT reconstructions using Astonish in AutoSPECT Pro on Intellispace Portal.

• • Terminated Z-1125-2012 FDA Not yet classified ·initiated 27 Jan 2012

  There maybe incorrect values in the diffusion/perfusion maps.

• • Terminated Z-0293-2012 FDA Unclassified (pre-2012) ·initiated 3 Aug 2011

  The firm determined that during scanning procedures, for some larger patients, some reddening of the skin of can occur in certain instances due to RF heating when the torso of the patient is positioned within the body coil.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K110151 ↗

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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