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Achieva 1.5T & Inera 1.5T Family

by Philips Medical Systems Nederland B.V.

510(k) K052013

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

10 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052013 Date2 Aug 2005ClearedStatusActive

Recalls

27 recalls · 10 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-3232-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3240-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3233-2026 FDA Class II initiated 21 Aug 2026

    A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

  • 3 recalls, same reason

    • Ongoing Z-2165-2024 FDA Class I initiated 5 Jun 2024 on shared 510(k) K052013
    • Ongoing Z-2163-2024 FDA Class I initiated 5 Jun 2024 on shared 510(k) K052013
    • Ongoing Z-2164-2024 FDA Class I initiated 5 Jun 2024 on shared 510(k) K052013

    Potential for coils to heat up and harm patients (burn).

  • 4 recalls, same reason

    • Ongoing Z-0393-2024 FDA Class II initiated 23 Oct 2023
    • Ongoing Z-0392-2024 FDA Class II initiated 23 Oct 2023
    • Ongoing Z-0389-2024 FDA Class II initiated 23 Oct 2023
    • Ongoing Z-0390-2024 FDA Class II initiated 23 Oct 2023

    Potential component failure in the Gradient Coil could product smoke and/or fire.

  • 14 recalls, same reason

    • Terminated Z-0888-2019 FDA Class II initiated 21 Dec 2018
    • Terminated Z-0891-2019 FDA Class II initiated 21 Dec 2018
    • Terminated Z-0889-2019 FDA Class II initiated 21 Dec 2018
    • Terminated Z-0887-2019 FDA Class II initiated 21 Dec 2018
    • Terminated Z-0909-2019 FDA Class II initiated 21 Dec 2018
    • Terminated Z-0894-2019 FDA Class II initiated 21 Dec 2018
    • Terminated Z-0895-2019 FDA Class II initiated 21 Dec 2018
    • Terminated Z-0892-2019 FDA Class II initiated 21 Dec 2018
    • Terminated Z-0915-2019 FDA Class II initiated 21 Dec 2018
    • Terminated Z-0912-2019 FDA Class II initiated 21 Dec 2018
    • Terminated Z-0908-2019 FDA Class II initiated 21 Dec 2018
    • Terminated Z-0899-2019 FDA Class II initiated 21 Dec 2018
    • Terminated Z-0890-2019 FDA Class II initiated 21 Dec 2018
    • Terminated Z-0896-2019 FDA Class II initiated 21 Dec 2018

    There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

  • 2 recalls, same reason

    • Terminated Z-1433-2018 FDA Class II initiated 16 Mar 2018
    • Terminated Z-1435-2018 FDA Class II initiated 16 Mar 2018

    Potential risk for helium gas inside the MR examination room during a magnet quench

    • Terminated Z-2461-2010 FDA Unclassified (pre-2012) initiated 30 Sep 2008 on shared 510(k) K052013

    The cables of the coil may become too hot and cause burns when placed too close to the patient. While using the 1.5T Sense XL Torso coil, unwanted radiofrequencies (RF) interaction with the patient can occur. Especially in combination with high SAR levels and when the RF cables of the coil are too close to the patient, this RF interaction has resulted in RF burns to patients.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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