The Recall Desk

FDA (Devices) recall action 88461

Philips North America Llc recalled 7 products on 2021-09-01

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2021-09-01
Critical
0
Units
19

Why these products were recalled

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

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

1–7 of 7

  • HighFDA (Devices)··2021-09-01

    Philips Ingenia MRI System recalled due to incorrect pressure relief valve

    Philips recalled 27 units of the Ingenia 1.5T Magnetic Resonance system with an incorrect pressure relief valve (42 psi instead of 3.75 psi) that could release helium gas and cause injury.

    Product
    Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 7
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2021-09-01

    Philips Ingenia MRI System Equipped With Incorrect Pressure Relief Valve

    Philips Ingenia Elition X MRI systems contain an incorrectly installed pressure relief valve that may release helium gas and cause injury. The recall affects 6 U.S. units and 12 units distributed internationally.

    Product
    Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Numb
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2021-09-01

    MRI System Pressure Relief Valve Defect May Cause Helium Release

    Philips Achieva 3.0T MRI systems may have an incorrectly installed pressure relief valve that could release helium gas and cause injury. Affected units are distributed in the United States and internationally.

    Product
    Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 7
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2021-09-01

    Diagnostic MRI system recalled for pressure relief valve defect

    A Philips Ingenia MRI system has been recalled due to installation of a 42 psi pressure relief valve instead of the correct 3.75 psi valve, which may result in helium gas release and injury.

    Product
    Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 7
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2021-09-01

    MRI System Pressure Relief Valve Installation Error May Release Helium Gas

    Philips MRI systems may have incorrect pressure relief valves installed, risking helium gas release and injury. Seven units contain 42 psi valves instead of required 3.75 psi valves.

    Product
    Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Numb
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2021-09-01

    MRI System Pressure Relief Valve Defect May Release Helium Gas

    Philips MRI systems contain an incorrectly rated pressure relief valve that may release helium gas and cause injury. The system was installed with a 42 psi valve instead of the required 3.75 psi valve.

    Product
    Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model N
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2021-09-01

    MRI System Pressure Valve Installation Error Poses Helium Release Risk

    A wrong pressure relief valve was installed in Ingenia CX 3.0T MRI systems, which may release helium gas and cause injury to patients and staff.

    Product
    Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number
    Category
    Distribution
    12 states