The Recall Desk

Hazard

Helium Release recalls

11 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
11
Critical
5
Severe
0
Most recent
2026-01-21

Of the 11 helium release recalls we have scored against our rubric, 5 (45%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all helium release recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–11 of 11

  • HighFDA (Devices)·Z-1071-2026·2026-01-21

    MRI systems recalled over ice that may block the magnet venting system

    Canon Medical Systems is recalling 34 Vantage Galan 3T MRI systems because ice may form in the venting system, and a quench in that condition could rupture the helium vessel.

    Product
    Allura Xper FD20 Biplane; Model Number: 722013;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0431-2026·2025-11-19

    MRI upgrade recalled over ice blockage in helium venting paths

    Siemens Medical Solutions is recalling four MAGNETOM Cima.X Upgrade systems because an ice blockage may form in the magnet's helium venting paths. The FDA has classified it Class I.

    Product
    MAGNETOM Cima.X Upgrade. Model Number: 11689304.
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0163-2026·2025-11-05

    MRI operating suites recalled over ice blockage in the magnet venting system

    IMRIS is recalling the IMRIS iMRI 3T V Operating Suite because an ice blockage in the Siemens 3 Tesla magnet's venting system could rupture the helium containment system during a quench. The FDA classified it Class I.

    Product
    IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0162-2026·2025-11-05

    MRI operating suites with Skyra magnet recalled over venting system blockage

    IMRIS is recalling the IMRIS iMRI 3T S Operating Suite because an ice blockage in the Siemens 3 Tesla Skyra magnet's venting system could rupture the helium containment system during a quench.

    Product
    IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0164-2026·2025-11-05

    InVision operating suite recalled over ice blockage in magnet venting paths

    IMRIS is recalling the InVision 3T Operating Suite because an ice blockage in the Siemens 3 Tesla Vida magnet's venting system could rupture the helium containment system during a quench.

    Product
    IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0161-2026·2025-11-05

    Neuro operating suites recalled over ice blockage in magnet venting paths

    IMRIS is recalling the Neuro III-SV iMRI and iMRX systems because an ice blockage in the Siemens 3 Tesla Verio magnet's venting system could rupture the helium containment system during a quench.

    Product
    IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2346-2021·2021-09-01

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2344-2021·2021-09-01

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2343-2021·2021-09-01

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2347-2021·2021-09-01

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2341-2021·2021-09-01

    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
    Medical Device
    Distribution
    Distributed nationwide