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Philips CT Big Bore

by Philips Medical Systems (Cleveland), Inc. United States 510(k)

510(k) K171850

Product code JAK

Regulatory status

as of 25 Oct 2026

Recall ongoing. 5 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171850 Date9 Nov 2017ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls

14 recalls · 5 ongoing · FDA

    • Ongoing Z-2597-2025 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-1660-2025 FDA Class II initiated 1 Apr 2025

    Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

  • 3 recalls, same reason

    • Ongoing Z-0294-2024 FDA Class II initiated 9 Oct 2023
    • Ongoing Z-0293-2024 FDA Class II initiated 9 Oct 2023
    • Ongoing Z-0292-2024 FDA Class II initiated 9 Oct 2023

    For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.

  • 9 recalls, same reason

    • Terminated Z-0309-2019 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0311-2019 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0307-2019 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0310-2019 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0303-2019 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0304-2019 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0306-2019 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0308-2019 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0305-2019 FDA Class II initiated 7 Jun 2017

    It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
JAK
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Philips Medical Systems (Cleveland), Inc.

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K171850 24 fields · synced 22 Oct 2026