# K012009: MX8000 Idt CT System

- Pathway: 510(k) (Traditional)
- Applicant: Marconi Medical Systems, Inc.
- Decided: Sep 13, 2001 after 78 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 61 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930090 (1993). 8 ancestors in all.
263 later devices descend from it; 11 cite it directly.
0 of 272 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982060: Volumax CT Imaging System, Elscint, Inc. (1998) Summary page 2.
- K010817: MX8000 V5.0 CT System, Philips Medical Systems (Cleveland), Inc. (2001) Summary page 2.

## Most influential descendants
- K033326: Philips Plus Computed Tomography System (2003), 214 descendants of its own
- K042293: Brilliance CT, Private Practice CV Configuration, CT Scanner (2004), 147 descendants of its own
- K130159: Qlab Quantification Software Heart Model (2013), 92 descendants of its own
- K132165: Qlab Quantification Software (2013), 91 descendants of its own
- K032036: Gemini 16 (2003), 87 descendants of its own

## Recalls of this device
- Aug 13, 2025 · Class II · Z-2596-2025: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- May 1, 2021 · Class II · Z-1981-2021: 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
- Oct 18, 2018 · Class II · Z-0548-2019: 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
- Oct 18, 2018 · Class II · Z-0545-2019: 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
- Oct 18, 2018 · Class II · Z-0547-2019: 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
- Oct 18, 2018 · Class II · Z-0546-2019: 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
- Jul 3, 2018 · Class II · Z-1142-2019: 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 fai
- Mar 30, 2018 · Class II · Z-2175-2018: 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 interv
- Mar 30, 2018 · Class II · Z-2176-2018: 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 interv
- Feb 8, 2018 · Class II · Z-1412-2018: Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- Feb 8, 2018 · Class II · Z-1415-2018: Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- Jul 20, 2016 · Class II · Z-2656-2016: 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 r
- Jul 20, 2016 · Class II · Z-2655-2016: 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 r
- Mar 24, 2016 · Class II · Z-2370-2016: Software defect causing intermittently slow response of Host.
- Mar 24, 2016 · Class II · Z-2369-2016: Software defect causing intermittently slow response of Host.
- Mar 4, 2016 · Class II · Z-1506-2016: 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 ot
- Sep 14, 2015 · Class II · Z-0173-2016: The firm discovered Ring/Dot artifact due to X-ray measurement error.
- Mar 16, 2015 · Class II · Z-1651-2015: 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.
- Mar 16, 2015 · Class II · Z-1652-2015: 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.
- Mar 16, 2015 · Class II · Z-1653-2015: 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.
- Mar 16, 2015 · Class II · Z-1654-2015: 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.
- Mar 16, 2015 · Class II · Z-1655-2015: 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.
- Mar 6, 2015 · Class II · Z-1766-2015: 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, overh
- Mar 6, 2015 · Class II · Z-1765-2015: 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, overh
- Mar 6, 2015 · Class II · Z-1793-2015: 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, overh
- Dec 8, 2014 · Class II · Z-0979-2015: Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
- Jul 27, 2014 · Class II · Z-2237-2014: 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 
- Apr 1, 2014 · Class II · Z-1722-2014: A customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged.
- Mar 27, 2014 · Class II · Z-1461-2014: 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 l
- Mar 11, 2014 · Class II · Z-1678-2014: 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, resolutio
- Aug 30, 2013 · Class II · Z-0013-2014: There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds.
- Jul 5, 2013 · Class II · Z-2210-2013: The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch.
- Mar 12, 2013 · Class II · Z-1338-2013: 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
- Dec 20, 2012 · Class II · Z-0945-2013: 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 ma
- Oct 24, 2012 · Class II · Z-0881-2013: 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 
- Aug 28, 2012 · Class III · Z-2404-2012: 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.
- Aug 21, 2012 · Class II · Z-2451-2012: 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.
- Aug 3, 2012 · Class II · Z-2245-2012: The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch.
- Jul 2, 2012 · Class II · Z-2035-2012: 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 defecti
- May 23, 2012 · Class II · Z-1988-2012: 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 
- May 23, 2012 · Class II · Z-1987-2012: 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 Sensiti
- May 22, 2012 · Class II · Z-2000-2012: 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 
- Mar 26, 2012 · Not classified · Z-1693-2012: 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 sever
- Mar 26, 2012 · Not classified · Z-1692-2012: 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 sever
- Mar 26, 2012 · Not classified · Z-1691-2012: 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 sever
- Mar 26, 2012 · Not classified · Z-1690-2012: 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 sever
- Sep 15, 2011 · Not classified · Z-0182-2012: 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 eject
- Dec 10, 2010 · Not classified · Z-1669-2011: 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 
- Jul 27, 2010 · Not classified · Z-0133-2011: 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 collimati
- Oct 3, 2009 · Not classified · Z-1819-2011: 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

## Indications for use
The Mx8000 IDT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

Source page: https://510kreport.com/device/K012009
Methodology: https://510kreport.com/methodology