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Achieva, Intera and Panorama 1.0 Release 2-Series

by Philips Medical Systems Nederland B.V.

510(k) K052078

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

9 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 NumberK052078 Date7 Sep 2005ClearedStatusActive

Recalls

12 recalls · 9 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-3234-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3233-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3232-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3240-2026 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.

    • Ongoing Z-0505-2024 FDA Class I initiated 17 Nov 2023

    Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is unable to contain the pressured helium gas due to an unforeseen blockage in the system, risks to patients and/or operators that may lead to injury or death include chemical exposure (i.e. helium gas) that may expand to surrounding rooms, contusion caused by debris, and asphyxia.

  • 4 recalls, same reason

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

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

  • 2 recalls, same reason

    • Terminated Z-0876-2019 FDA Class II initiated 21 Dec 2018
    • Terminated Z-0875-2019 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.

    • Terminated Z-1307-2015 FDA Class II initiated 20 Nov 2014

    VCG battery ignited in a VCG unit when recharging.

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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