Philips iCT CT System

• • Ongoing Z-2598-2025 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.

• • Terminated Z-2314-2021 FDA Class II ·initiated 8 Jun 2021

  When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

• 2 recalls, same reason

  • Terminated Z-2190-2019 FDA Class II ·initiated 24 Jun 2019
  • Terminated Z-2189-2019 FDA Class II ·initiated 24 Jun 2019

  In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied

• • Terminated Z-1144-2019 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.

• • Terminated Z-0388-2018 FDA Class II ·initiated 10 Nov 2017

  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 is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.

510(k) Number

K162838 ↗

FDA product code

JAK

Device class

Class II

Regulation

21 CFR Part 892.1750

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

• IQon Spectral CT Open recall

  Class II

  FDA 510(k) K163711 Active Cleared 5 Apr 2017

• Philips CT Big Bore Open recall

  Class II

  FDA 510(k) K171850 Active Cleared 9 Nov 2017

• Philips 459801630821 Open recall

  Class II

  FDA 510(k) K170086 Active Cleared 9 Feb 2017 GUDID on market

• Pinnacle Radiation Therapy Planning System 18.0 Open recall

  Class II

  FDA 510(k) K170086 Active Cleared 9 Feb 2017 GUDID on market

• Edge/Vista System Enhancement Package

  Class II

  FDA 510(k) K964626 Active Cleared 10 Feb 1997

• Uhe Collimator (210591)

  Class II

  FDA 510(k) K963406 Active Cleared 26 Feb 1997

See all devices from Philips Medical Systems (Cleveland), Inc. →

• What is the Philips iCT CT System used for?

  The Philips iCT CT System is a computed tomography (CT) scanner designed for diagnostic imaging applications in radiology, enabling detailed internal body imaging to support clinical diagnosis and treatment planning.

• Is the Philips iCT CT System sterile or non-sterile, and is it intended for single-use or reuse?

  The Philips iCT CT System is supplied as a non-sterile, reusable system, meaning it is not provided in a sterile condition and is designed for multiple uses after appropriate cleaning and disinfection procedures in clinical radiology environments.

• What regulatory pathway was used for the Philips iCT CT System, and what is its product code?

  The Philips iCT CT System received FDA 510(k) clearance, demonstrating substantial equivalence to a legally marketed device, and is classified under product code JAK, which pertains to computed tomography x-ray systems.