MX8000 IDT CT System

• • Ongoing Z-2596-2025 FDA Class II ·initiated 13 Aug 2025

  The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

• • Ongoing Z-1981-2021 FDA Class II ·initiated 1 May 2021

  Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

• 4 recalls, same reason

  • Terminated Z-0547-2019 FDA Class II ·initiated 18 Oct 2018
  • Terminated Z-0546-2019 FDA Class II ·initiated 18 Oct 2018
  • Terminated Z-0548-2019 FDA Class II ·initiated 18 Oct 2018
  • Terminated Z-0545-2019 FDA Class II ·initiated 18 Oct 2018

  There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall

• • Terminated Z-1142-2019 FDA Class II ·initiated 3 Jul 2018

  Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.

• 2 recalls, same reason

  • Terminated Z-2176-2018 FDA Class II ·initiated 30 Mar 2018
  • Terminated Z-2175-2018 FDA Class II ·initiated 30 Mar 2018

  The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.

• 2 recalls, same reason

  • Terminated Z-1412-2018 FDA Class II ·initiated 8 Feb 2018
  • Terminated Z-1415-2018 FDA Class II ·initiated 8 Feb 2018

  Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

• 2 recalls, same reason

  • Terminated Z-2655-2016 FDA Class II ·initiated 20 Jul 2016
  • Terminated Z-2656-2016 FDA Class II ·initiated 20 Jul 2016

  After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.

• 2 recalls, same reason

  • Terminated Z-2369-2016 FDA Class II ·initiated 24 Mar 2016
  • Terminated Z-2370-2016 FDA Class II ·initiated 24 Mar 2016

  Software defect causing intermittently slow response of Host.

• • Terminated Z-1506-2016 FDA Class II ·initiated 4 Mar 2016

  The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90 or 180 relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.

• • Terminated Z-0173-2016 FDA Class II ·initiated 14 Sep 2015

  The firm discovered Ring/Dot artifact due to X-ray measurement error.

• 5 recalls, same reason

  • Terminated Z-1655-2015 FDA Class II ·initiated 16 Mar 2015
  • Terminated Z-1653-2015 FDA Class II ·initiated 16 Mar 2015
  • Terminated Z-1654-2015 FDA Class II ·initiated 16 Mar 2015
  • Terminated Z-1651-2015 FDA Class II ·initiated 16 Mar 2015
  • Terminated Z-1652-2015 FDA Class II ·initiated 16 Mar 2015

  The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

• 3 recalls, same reason

  • Terminated Z-1766-2015 FDA Class II ·initiated 6 Mar 2015
  • Terminated Z-1793-2015 FDA Class II ·initiated 6 Mar 2015
  • Terminated Z-1765-2015 FDA Class II ·initiated 6 Mar 2015

  The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

• • Terminated Z-0979-2015 FDA Class II ·initiated 8 Dec 2014

  Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.

• • Terminated Z-2237-2014 FDA Class II ·initiated 27 Jul 2014

  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 (

• • Terminated Z-1722-2014 FDA Class II ·initiated 1 Apr 2014

  A customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged.

• • Terminated Z-1461-2014 FDA Class II ·initiated 27 Mar 2014

  Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. As a result, the table top can become free floating due to the disengaged service latch in the table tops subframe.

• • Terminated Z-1678-2014 FDA Class II ·initiated 11 Mar 2014 ·on shared 510(k) K012009

  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-0013-2014 FDA Class II ·initiated 30 Aug 2013

  There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds.

• • Terminated Z-2210-2013 FDA Class II ·initiated 5 Jul 2013

  The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch.

• • Terminated Z-1338-2013 FDA Class II ·initiated 12 Mar 2013

  Philips Healthcare received a report from the field stating when they viewed the CTDIVol information from the PACS system, the calculations were too high. Instead of storing the CTDIVol value for each slice in the DICOM tag, the system took the sum of all CTDIVol values from all the images in the dataset and stored this value in the DICOM tag, resulting in incorrect information.

• • Terminated Z-0945-2013 FDA Class II ·initiated 20 Dec 2012

  Philips Healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Philips has determined the cause was a malfunction of the vertical brake.

• • Terminated Z-0881-2013 FDA Class II ·initiated 24 Oct 2012

  Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project

• • Terminated Z-2404-2012 FDA Class III ·initiated 28 Aug 2012

  Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button.

• • Terminated Z-2451-2012 FDA Class II ·initiated 21 Aug 2012

  A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.

• • Terminated Z-2245-2012 FDA Class II ·initiated 3 Aug 2012

  The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch.

• • Terminated Z-2035-2012 FDA Class II ·initiated 2 Jul 2012

  Philips Healthcare was notified that several of the sixteen bolts securing the brackets which support the carbon table top on various models of their Brilliant CT scanner have been found to be defective and the bolt heads may break off.

• • Terminated Z-1987-2012 FDA Class II ·initiated 23 May 2012

  The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area when the customer uses the "Time Sensitive" and "Time Insensitive" methods.

• • Terminated Z-1988-2012 FDA Class II ·initiated 23 May 2012

  Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances. The most frequent and severe non-conformance identified involves the portal setting of "PAC Integration". This setting has a feature that allows the user to launch images of multiple patient studies into an application, but does not display a warning message informing the user that diff

• • Terminated Z-2000-2012 FDA Class II ·initiated 22 May 2012

  In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using the editing mode "edit contour" tool, the measurements are not recalculated causing discrepancies with the lesion measurements.

• 4 recalls, same reason

  • Terminated Z-1690-2012 FDA Not yet classified ·initiated 26 Mar 2012
  • Terminated Z-1691-2012 FDA Not yet classified ·initiated 26 Mar 2012
  • Terminated Z-1692-2012 FDA Not yet classified ·initiated 26 Mar 2012
  • Terminated Z-1693-2012 FDA Not yet classified ·initiated 26 Mar 2012

  Component defect. Following their receipt of a customer complaint, Philips Medical determined that the metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm's CT scanning systems were not manufactured to specification and may crack.

• • Terminated Z-0182-2012 FDA Unclassified (pre-2012) ·initiated 15 Sep 2011 ·on shared 510(k) K012009

  A problem related to a software error has been detected in the Philips Multiple Gated Radionuclide Angiocardiography (MUGA) application. A false negative interpretation due to a falsely elevated ejection fraction or a false positive interpretation due to a false low ejection fraction could occur.

• • Terminated Z-1669-2011 FDA Unclassified (pre-2012) ·initiated 10 Dec 2010 ·on shared 510(k) K012009

  Philips Medical Systems has decided to recall the patient support vertical brake hub in all its Brilliance systems due to the collapse in the vertical direction. The short key connecting the vertical brake hub to the motor shaft can disengage due to the lack of thread locker on set screws.

• • Terminated Z-0133-2011 FDA Unclassified (pre-2012) ·initiated 27 Jul 2010

  Philips Healthcare has decided to recall the Computed Tomography X-Ray System MX 8000 IDT due to the fact that the software upgrade for the MX 8000 IDT 16 v4.2.1 may not provide the optional collimation of 4x4.5 (18mm). If the customer does not verify the increment and thickness coincide with the newly selected collimation suggested by the conversion report, there is potential for a 6mm gap to ap

• • Terminated Z-1819-2011 FDA Unclassified (pre-2012) ·initiated 3 Oct 2009 ·on shared 510(k) K012009

  During an FDA inspection on 10/1/2010 the firm was notified by FDA that their field action they initiated in Oct 2009, constituted a recall. The firm determined that the functional analysis feature in the Comprehensive Cardiac Analysis (CCA) was displaying incorrect values on the polar fields. The calculated results for the myocardial wall thickening was incorrect in that the numbers displayed f

• • Terminated Z-1568-2009 FDA Unclassified (pre-2012) ·initiated 27 Apr 2009 ·on shared 510(k) K012009

  Philips Healthcare has decided to recall the Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1 due to the fact that when images are saved or filmed that contain the Curved Multi-planar Reformation Section (cMPRS) views that were created with a short curve the Right/Left annotations will be reversed.

• • Terminated Z-0597-2009 FDA Unclassified (pre-2012) ·initiated 23 Sep 2008 ·on shared 510(k) K012009

  The product is being recalled because the patient support may travel downwards without being commanded to move.

• • Terminated Z-0132-2009 FDA Unclassified (pre-2012) ·initiated 22 Sep 2008 ·on shared 510(k) K012009

  Images not correlated: A leak between the Tube Interface and the Outlet Tube of the transducer may result in a failure to produce respiratory correlated images.

• • Terminated Z-0366-2008 FDA Unclassified (pre-2012) ·initiated 10 Sep 2007

  Incorrect Measurement: Incorrect measurement will occur when the operator uses the distance or area measurement function, such as Graphic Tool line or ROI on zoomed and batch saved images from the Cardiac Viewer or Pulmonary Viewer and then views them in the CT Viewer or on a PACS System.

• 3 recalls, same reason

  • Terminated Z-1416-05 FDA Unclassified (pre-2012) ·initiated 11 Mar 2005
  • Terminated Z-1411-05 FDA Unclassified (pre-2012) ·initiated 11 Mar 2005
  • Terminated Z-1415-05 FDA Unclassified (pre-2012) ·initiated 11 Mar 2005

  When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.

• • Terminated Z-0889-06 FDA Unclassified (pre-2012) ·initiated 2 Aug 2004 ·on shared 510(k) K012009

  Due to a software deficiency that occurs in the combine mode, a patients image can be filmed over a different patients image.

• 2 recalls, same reason

  • Terminated Z-0787-04 FDA Unclassified (pre-2012) ·initiated 8 Mar 2004
  • Terminated Z-0786-04 FDA Unclassified (pre-2012) ·initiated 8 Mar 2004

  The CT couch may move downward to its lower limit without command.

• • Terminated Z-0835-03 FDA Unclassified (pre-2012) ·initiated 2 Apr 2003

  Patient images may be incorrectly stored in the archive directory of a different patient.

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

510(k) Number

K012009 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Boluspro Ultra

  Class II

  FDA 510(k) K002005 Active Cleared 22 Sep 2000

• What is the MX8000 IDT CT System used for in clinical settings?

  The MX8000 IDT CT System is designed for detailed cross-sectional imaging of internal body structures, enabling radiologists to evaluate anatomical and pathological conditions. Its advanced capabilities support assessments of complex areas such as the chest, abdomen, and vascular systems, making it ideal for diagnostic purposes in radiology departments.

• Is the MX8000 IDT CT System single-use or reusable?

  The provided data does not explicitly state whether the MX8000 IDT CT System is intended for single-use or reuse. Typically, CT scanners are reusable systems requiring proper maintenance and cleaning protocols to ensure patient safety and imaging accuracy. For specific handling instructions, refer to the manufacturer’s operational guidelines.

• What regulatory pathway was followed for FDA clearance of this device?

  The MX8000 IDT CT System received FDA clearance under the 510(k) pathway, demonstrating substantial equivalence to predicate devices. This classification falls under product code JAK, categorized as a 'System, X-ray, Tomography, Computed,' and was reviewed by the Radiology Advisory Committee (RA). The clearance decision was made on September 13, 2001.

• Are there specific storage or handling requirements for the MX8000 IDT CT System?

  The regulatory submission for the MX8000 IDT CT System does not provide detailed storage or handling instructions. As a medical imaging system, it should be stored in a controlled environment to protect against physical damage, electromagnetic interference, and environmental factors that could affect performance. Always follow the manufacturer’s operational manual for proper setup and maintenance.

• What distinguishes the MX8000 IDT CT System from other CT scanners?

  The MX8000 IDT CT System is distinguished by its advanced imaging technology, enabling high-resolution cross-sectional scans of internal structures. While the exact technical specifications are not detailed in the provided data, its FDA clearance under the 510(k) pathway and classification as a computed tomography system suggest it is designed for comprehensive diagnostic evaluations in radiology, particularly for complex anatomical regions like the chest, abdomen, and vascular systems.