The Recall Desk

FDA (Devices) recall action 82038

Philips Medical Systems Nederlands recalled 64 products on 2019-03-06

The FDA (Devices) publishes a recall like this one as 64 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 64 pages.

Products
64
Announced
2019-03-06
Critical
0
Units
718,464

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

51–64 of 64

  • SevereFDA (Devices)··2019-03-06

    Philips Multiva MRI System Recalled Due to Ceiling Speaker Hazard

    Philips is recalling 11,226 Multiva MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Multiva 1.5T 16 R5, Model Number 781078. Nuclear Magnetic Resonance Imaging System
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-03-06

    Philips MRI Systems Recalled Due to Ceiling Speaker Fall Risk

    Philips is recalling Intera 1.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Intera 1.0T Omni/Stellar, Model Number 781102. Nuclear Magnetic Resonance Imaging System
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-03-06

    Philips Intera 3.0T MRI System Recalled for Ceiling Speaker Hazard

    Philips is recalling Intera 3.0T MRI systems because ceiling speakers may fall due to magnetic attraction.

    Product
    Intera 3.0T Master/Quasar Dual, Model Number 781150. Nuclear Magnetic Resonance Imaging System
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-03-06

    Philips Achieva 3.0T MRI System Recalled for Falling Speaker Hazard

    Philips is recalling 11,226 Achieva 3.0T MRI systems because ceiling speakers may fall due to magnetic attraction.

    Product
    Achieva 3.0T TX for PET, Model Number 781479. Nuclear Magnetic Resonance Imaging System
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-03-06

    Philips MRI System Recall Due to Ceiling Speaker Magnetic Hazard

    Philips is recalling Intera 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Intera 1.5T Master/Nova, Model Number 781106. Nuclear Magnetic Resonance Imaging System
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-03-06

    Philips MRI System Recall Due to Ceiling Speaker Magnetic Hazard

    Philips is recalling Intera Achieva 1.5T MRI systems because ceiling speakers may be pulled by the magnetic field and fall.

    Product
    Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonance Imaging System
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-03-06

    Philips MR-OR 1.5T MRI Systems Recalled for Falling Speaker Hazard

    Philips is recalling 11,226 MR-OR 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-03-06

    Philips Achieva 1.5T MRI System Recalled Due to Falling Speaker Hazard

    Philips Medical Systems is recalling 11,226 Achieva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System
    Category
    Distribution
    0 states