Ingenia Ingenia 3.0T CX (REF 781271)Recalls & reported problems
Philips Medical Systems Nederland B.V. · Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. · Class 2
All models of Ingenia (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
9 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Philips Ingenia 3.0T CX is a wide-bore MRI scanner that produces cross-sectional and spectroscopic images of the head, body or limbs. Of 59 adverse event reports, most describe the rubber seal on the body coil detaching or breaking, leaving sharp magnet cover edges that can scrape patients; 11 mention injuries and none mention deaths. Eleven recalls name this device, including several still open, covering scan export and image reconstruction software errors, a loose electrical connection that could cause smoke or fire, and a heat source in the gradient coil.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 11
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00884838068452), received between Sep 8, 2020 and Jun 24, 2026 — classified as 11 injuries, 48 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (48 reports).
11 FDA recall records name this device's identifier, 9 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Aug 28, 2026Class IIOpen, Classified
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
Z-3309-2026 · Root cause: Software design · Recall details · FDA record ↗
- Aug 21, 2026Class IIOpen, Classified
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.
Z-3238-2026 · Root cause: Software design · Recall details · FDA record ↗
- Apr 14, 2026Class IIOpen, Classified
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Z-1959-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Dec 3, 2025Class IIOpen, Classified
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Z-1208-2026 · Root cause: Software design · Recall details · FDA record ↗
- Jun 30, 2025Class IIOpen, Classified
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Z-2207-2025 · Root cause: Device Design · Recall details · FDA record ↗
- May 13, 2025Class IIOpen, Classified
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Z-1800-2025 · Root cause: Software design · Recall details · FDA record ↗
- May 3, 2024Class IIOpen, Classified
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Z-1849-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 12, 2024Class IIOpen, Classified
Patient support table floor plate may be incorrectly installed.
Z-1567-2024 · Root cause: Process design · Recall details · FDA record ↗
- Jan 3, 2024Class IIOpen, Classified
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Z-0951-2024 · Root cause: Process control · Recall details · FDA record ↗
- Aug 11, 2021Class IICompleted
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Z-2420-2021 · Root cause: Device Design · Recall details · FDA record ↗
- Jul 30, 2021Class IITerminated
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
Z-2345-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component48
- Insufficient Device Problem Information7
- Improper or Incorrect Procedure or Method5
- Adverse Event Without Identified Device or Use Problem3
- Device Handling Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- Multiple Fractures3
- Bone Fracture(s)2
- Burning Sensation1
- Eye Injury1
- Inflammation1
- Laceration(s)1
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL HAD BECOME DETACHED. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DETACHED, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25604002 ↗MalfunctionMay 13, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL STRIP WAS LOOSE. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS LOOSE, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157026 ↗MalfunctionMay 7, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE RUBBER STRIP ON THE QUADRATURE BODY COIL (QBC) HAD COME OFF. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGED/COMES OFF, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25109712 ↗MalfunctionApr 17, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE INNER QUADRATURE BODY COIL (QBC) SEAL WAS DAMAGED. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24908213 ↗MalfunctionMar 30, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS DETACHED. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DETACHED, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24725596 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL HAD BEEN DAMAGED AS THE MAGNET HOLE ADHESIVE STRIP HAD COME OFF. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24685659 ↗InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
PHILIPS RECEIVED A REPORT THAT UPON THE ENTRY INTO THE MRI SCANNER FOR A PELVIC SCAN, THE PATIENT IS LYING DOWN WITH THE ANTERIOR COIL, FEET FORWARD. THE PATIENT GRAZED HIS NASAL SEPTUM WITH THE ANTERIOR COIL. DESCRIBED AS A SCRATCH FROM THE COIL'S FRICTION THAT DID NOT REQUIRE TREATMENT. THE PATIENT HAD AN IV LINE FOR CONTRAST ON UNKNOWN ARM. PHLEBITIS OCCURRED AS A CONSEQUENCE OF BENDING THE ARM AT THE SITE WHERE THE INTRAVENOUS LINE WAS INSERTED. SUBSEQUENT TREATMENT WITH SODIUM HEPARIN ADMINISTERED TO THE AREA OF PHLEBITIS, AS THE COIL, DURING MOVEMENT, DISLODGED THE VENOUS ACCESS ROUTE. THE PATIENT'S CURRENT STATUS WAS REPORTED AS "FINE ON JAN 05 2026". THE STUDY WAS PERFORMED ON ANOTHER MRI SCANNER AT THE CLIENT LOCATION. THE ADMINISTRATION OF SODIUM HEPARIN TO TREAT THE REPORTED PHLEBITIS RELATED TO THE IV BEING DISLODGED BY THE REPORTED EVENT, MEETS THE CRITERIA FOR A SERIOUS INJURY.
Patient problems: Inflammation; Unintended Loss of Vascular Access
MAUDE report 24186924 ↗MalfunctionJan 9, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS BROKEN (DAMAGED). THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24017788 ↗MalfunctionJan 5, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS DEFECTIVE. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DEFECTIVE IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23955066 ↗MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS BROKEN. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS BROKEN IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476407 ↗MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS FALLEN OFF. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS FALLEN OFF IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23414549 ↗MalfunctionAug 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS DAMAGED. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22847195 ↗MalfunctionAug 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS DAMAGED. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22698005 ↗MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL CAME OFF. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL CAME OFF IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22468606 ↗MalfunctionJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE SEAL RUBBER WAS BROKEN (DAMAGED). THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22455589 ↗MalfunctionJul 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS LOOSE (DETACHED). THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS LOOSE, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22401609 ↗MalfunctionJun 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS DETACHED (LOOSE). THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS LOOSE IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22355599 ↗InjuryMay 27, 2025Device Handling Problem; Device Handling Problem
PHILIPS RECEIVED A REPORT THAT A PATIENT WAS CUT ON THE EDGE OF THE PATIENT SUPPORT. DURING HORIZONTAL TRAVEL OF THE PATIENT SUPPORT, THE PATIENT'S FINGERS WERE IN THE GAP BETWEEN THE TOP AND THE PATIENT SUPPORT AND WERE PINCHED RESULTING IN THE CUT. THE PATIENT WAS NOT UNDER ANESTHESIA AND THE SCAN WAS COMPLETED. THE CUT WAS ON THE PERIPHERAL JOINT OF THE LEFT RING FINGER. SEVEN SUTURES WERE PLACED TO CLOSE THE INJURY. THE PATIENT IS EXPECTED TO FULLY RECOVER ONCE THE SUTURES HAVE BEEN REMOVED.
Patient problems: Laceration(s)
MAUDE report 22085954 ↗MalfunctionMay 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS LOOSE. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS LOOSE IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22045312 ↗MalfunctionApr 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL IS DAMAGED. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21760120 ↗MalfunctionMar 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL IS LOOSE. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21676413 ↗MalfunctionMar 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS LOOSE. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS LOOSE IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21592387 ↗MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS FALLING OFF. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21558891 ↗MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS LOOSE. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21558496 ↗MalfunctionMar 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL IS COMING LOOSE. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21524227 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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