The Recall Desk

FDA (Devices) recall action 79451

Philips Electronics North America Corporation recalled 13 products on 2018-04-25

The FDA (Devices) publishes a recall like this one as 13 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 13 pages.

Products
13
Announced
2018-04-25
Critical
0
Units
106,665

Why these products were recalled

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

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.

States named across these recalls

1–13 of 13

  • HighFDA (Devices)··2018-04-25

    Philips Panorama 1.0T MRI Recalled for Helium Gas Release Risk

    Philips is recalling Panorama 1.0T MRI scanners due to a potential risk of helium gas release into the examination room during a magnet quench.

    Product
    Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-25

    Philips Multiva MRI Systems Recalled for Helium Gas Risk During Quench

    Philips is recalling 8,205 Multiva MRI systems worldwide due to a potential risk of helium gas release in the examination room during a magnet quench.

    Product
    Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Multiva 1.5T Model 781076, & 5) Multiva 1.5T 16ch R5 based Model 781078 Product Usage: Indicated for use as a diagnostic device. It can…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-25

    Philips Ingenia 1.5T CX MRI Recall for Helium Gas Risk

    Philips is recalling Ingenia 1.5T CX MRI scanners due to a potential risk of helium gas release into the examination room during a magnet quench.

    Product
    Ingenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-25

    Philips MRI Software Recall Due to Helium Gas Risk During Quench

    Philips is recalling the SmarthPath to dStream conversion software for 1.5T MRI systems due to a potential risk of helium gas release during a magnet quench.

    Product
    Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-25

    Philips Multiva MRI Systems Recalled for Helium Gas Quench Risk

    Philips is recalling 8,205 Multiva MRI systems worldwide due to a potential risk of helium gas release during a magnet quench.

    Product
    Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4) Magnet HFO, Model 781495, 5) Magnet Multiva 16, Model 781496, 6) Magnet Multiva 8, Model 781497 & 7) Magnets Ingenia 1.5T CX, Model 781498 Product…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-25

    Philips Intera 1.0T MRI Systems Recalled for Helium Gas Risk

    Philips is recalling 8,205 Intera 1.0T MRI systems worldwide due to a potential risk of helium gas release during a magnet quench.

    Product
    Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-25

    Philips T10-NT MRI Systems Recalled for Helium Gas Risk

    Philips is recalling 8,205 T10-NT MRI systems due to a potential risk of helium gas release in the examination room during a magnet quench.

    Product
    T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-25

    Philips T5-NT MRI Scanner Recalled for Helium Gas Risk

    Philips is recalling 8,205 T5-NT MRI scanners worldwide due to a potential risk of helium gas release in the examination room during a magnet quench.

    Product
    T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-25

    Philips Intera 1.5T MRI Systems Recalled for Helium Gas Risk

    Philips is recalling Intera 1.5T MRI systems due to a potential risk of helium gas release during a magnet quench.

    Product
    Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-25

    Philips Intera 0.5T MRI Recalled for Helium Gas Risk

    Philips is recalling 8,205 Intera 0.5T MRI scanners worldwide due to a potential risk of helium gas release during a magnet quench.

    Product
    Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-25

    Philips T5 MRI Scanner Recalled for Helium Gas Risk

    Philips is recalling T5 MRI scanners due to a potential risk of helium gas release during a magnet quench.

    Product
    T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-25

    Philips Achieva 1.5T MRI Systems Recalled for Helium Gas Risk

    Philips is recalling 8,205 Achieva 1.5T MRI systems worldwide due to a potential risk of helium gas release during a magnet quench.

    Product
    Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-25

    Philips ACS-NT MRI Scanner Recalled for Helium Gas Leak Risk

    Philips is recalling 8,205 ACS-NT MRI scanners due to a potential risk of helium gas release into the examination room during a magnet quench.

    Product
    ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Distribution
    1 state