# K033326: Philips Plus Computed Tomography System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Oct 29, 2003 after 13 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 131 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930090 (1993). 9 ancestors in all.
214 later devices descend from it; 9 cite it directly.
0 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012009: MX8000 Idt CT System, Marconi Medical Systems, Inc. (2001)
- K010817: MX8000 V5.0 CT System, Philips Medical Systems (Cleveland), Inc. (2001)

## Most influential descendants
- 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
- K062650: EP Navigator Software (2006), 49 descendants of its own
- K171314: QLAB Advanced Quantification Software (2017), 45 descendants of its own

## Recalls of this device
- Aug 7, 2026 · Class II · Z-3043-2026: Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
- Aug 13, 2025 · Class II · Z-2595-2025: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- Aug 13, 2025 · Class II · Z-2604-2025: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- Aug 13, 2025 · Class II · Z-2602-2025: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- Aug 13, 2025 · Class II · Z-2603-2025: 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-1982-2021: 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-0543-2019: 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-0544-2019: 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-1143-2019: 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-2174-2018: 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 21, 2018 · Class II · Z-1396-2018: Surview scan with tube current lower than 30 mA is unable to be initialized.
- Feb 8, 2018 · Class II · Z-1406-2018: 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-1413-2018: 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-1407-2018: 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-1405-2018: 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-1404-2018: Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- Nov 10, 2017 · Class II · Z-0389-2018: Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system 
- Nov 12, 2016 · Class II · Z-0694-2017: Software error due to the filament on timer
- Nov 12, 2016 · Class II · Z-0693-2017: Software error due to the filament on timer
- Aug 24, 2016 · Class II · Z-0012-2017: The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstruc
- Aug 24, 2016 · Class II · Z-0009-2017: The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstruc
- Aug 24, 2016 · Class II · Z-0010-2017: The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstruc
- Aug 24, 2016 · Class II · Z-0011-2017: The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstruc
- Jul 20, 2016 · Class II · Z-2652-2016: 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-2658-2016: 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-2657-2016: 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
- Jun 21, 2016 · Class II · Z-2113-2016: 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 causing injury to patients, operators, by-standers and s
- Jun 21, 2016 · Class II · Z-2115-2016: 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 causing injury to patients, operators, by-standers and s
- Jun 21, 2016 · Class II · Z-2114-2016: 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 causing injury to patients, operators, by-standers and s
- Apr 29, 2016 · Class II · Z-2380-2016: Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 products that could affect the performance of the equipment.
- Apr 29, 2016 · Class II · Z-2385-2016: Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.
- Apr 29, 2016 · Class II · Z-2383-2016: Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuity CT products that could affect the performance of the equipment.
- Apr 29, 2016 · Class II · Z-2384-2016: Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.
- Apr 8, 2016 · Class II · Z-1875-2016: The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
- Apr 8, 2016 · Class II · Z-1872-2016: The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
- Apr 8, 2016 · Class II · Z-1873-2016: The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
- Apr 8, 2016 · Class II · Z-1874-2016: The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
- Apr 1, 2016 · Class II · Z-2117-2016: Philips Healthcare received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed 
- Apr 1, 2016 · Class II · Z-2118-2016: Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstruct
- Apr 1, 2016 · Class II · Z-2116-2016: Philips Healthcare received reports from the field that certain Brilliance 64 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed i
- Mar 24, 2016 · Class II · Z-2366-2016: Software defect causing intermittently slow response of Host.
- Mar 24, 2016 · Class II · Z-2371-2016: Software defect causing intermittently slow response of Host.
- Mar 24, 2016 · Class II · Z-2372-2016: 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
- Feb 5, 2016 · Class II · Z-1355-2016: 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-1351-2016: 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-1356-2016: 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-1354-2016: 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-0548-2016: 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-0547-2016: 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

## Indications for use
The “Philips Plus” is a Computed Tomography X-Ray System intended to produce 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/K033326
Methodology: https://510kreport.com/methodology