# K060937: Brilliance Volume

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jun 5, 2006 after 61 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: 5 generations back to K930090 (1993). 10 ancestors in all.
24 later devices descend from it; 8 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033326: Philips Plus Computed Tomography System, Philips Medical Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- K131773: Brilliance Ict (2013), 11 descendants of its own
- K133674: Philips Iqon Spectral CT (2014), 10 descendants of its own
- K163711: IQon Spectral CT (2017), 7 descendants of its own
- K193454: IQon Spectral CT (2020), 6 descendants of its own
- K203020: Spectral CT (2021), 5 descendants of its own

## Recalls of this device
- Aug 13, 2025 · Class II · Z-2599-2025: 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-1990-2021: 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
- Apr 13, 2021 · Class II · Z-1774-2021: Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
- Apr 6, 2020 · Class II · Z-1921-2020: The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
- Apr 6, 2020 · Class II · Z-1922-2020: The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
- Feb 8, 2018 · Class II · Z-1409-2018: 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-1408-2018: Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- Nov 8, 2017 · Class II · Z-0332-2018: There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a 
- Nov 8, 2017 · Class II · Z-0331-2018: There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a 
- Jul 11, 2017 · Class II · Z-0402-2018: Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acq
- Jul 11, 2017 · Class II · Z-0403-2018: Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acq
- Dec 23, 2016 · Class II · Z-1058-2017: During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
- Nov 25, 2016 · Class II · Z-1004-2017: Failure to correctly document the installation of four M12 Bolts into the system rotor.
- Oct 13, 2016 · Class III · Z-0594-2017: The product label does not include the correct current rating.
- Oct 13, 2016 · Class III · Z-0593-2017: The product label does not include the correct current rating.
- Jun 21, 2016 · Class II · Z-2112-2016: Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack.
- Apr 29, 2016 · Class II · Z-2382-2016: Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment.
- Apr 29, 2016 · Class II · Z-2381-2016: Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, could affect the performance of the equipment.
- 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
- Feb 5, 2016 · Class II · Z-1352-2016: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
- Feb 5, 2016 · Class II · Z-1353-2016: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
- Oct 29, 2015 · Class II · Z-0545-2016: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) with
- Oct 29, 2015 · Class II · Z-0546-2016: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) with
- Sep 6, 2015 · Class II · Z-1713-2016: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a c
- Sep 6, 2015 · Class II · Z-1715-2016: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a c
- Sep 6, 2015 · Class II · Z-1714-2016: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a c
- Apr 13, 2015 · Class II · Z-1695-2015: A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.
- Mar 16, 2015 · Class II · Z-1656-2015: 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-1767-2015: 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-1768-2015: 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-1769-2015: 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
- Feb 5, 2015 · Class II · Z-2256-2015: 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after s
- Feb 5, 2015 · Class II · Z-1359-2015: Philips discovered that a software defect exists in marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted.
- Feb 5, 2015 · Class II · Z-2255-2015: 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after s
- Dec 8, 2014 · Class II · Z-0979-2015: Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
- Jul 31, 2014 · Class II · Z-0236-2015: It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.
- 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
- Dec 9, 2013 · Class II · Z-0832-2014: Patient images exhibited ring artifacts.
- Oct 11, 2013 · Class II · Z-0335-2014: If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact th
- Jul 16, 2013 · Class II · Z-0831-2014: An artifact that resembles thrombus may appear on the image.
- 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
- 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-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 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 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 
- May 7, 2012 · Not classified · Z-1688-2012: On 3/5/2012, Philips Healthcare was notified of one incident involving a Brilliance iCT scanner that resulted in damage to the gantry and slight injury to the user when the heat exchanger detached fro
- May 7, 2012 · Class II · Z-1791-2012: Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. A revie

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

Source page: https://510kreport.com/device/K060937
Methodology: https://510kreport.com/methodology