Ingenia Ingenia 3.0T CX (REF 782105)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

7 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Philips Ingenia 3.0T MRI system makes internal body images. The 40 adverse event reports describe a scanner body-coil seal breaking or coming loose, exposing sharp edges; there were no deaths and no injuries. Reports fell from 36 to 4 in the past year. This device has 7 open recalls covering software that may end exams during reconstruction, overheating gradient coil parts, loose screws, mains-unit hotspots, table plate misinstallation, and seal adhesive failure.

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: 41
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 7

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00884838098312), received between Nov 26, 2024 and Sep 18, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (41 reports).

7 FDA recall records name this device's identifier, 7 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

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

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 ↗
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 ↗
Sep 3, 2024Class IIOpen, Classified
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Z-3196-2024 · Root cause: Under Investigation by firm · 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 ↗

Most reported problems

Device problems

Detachment of Device or Device Component41

Patient problems

No Clinical Signs, Symptoms or Conditions41

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 18, 2026Detachment of Device or Device Component
Philips received a report that the rubber on the Quadrature Body Coil (QBC) was peeling 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 50814013 ↗
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 24684439 ↗
MalfunctionMar 11, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL 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 24566973 ↗
MalfunctionFeb 2, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL UPPER 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 LOOSE IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232406 ↗
MalfunctionNov 14, 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 GASKET CAME OUT, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23551964 ↗
MalfunctionOct 31, 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 23434660 ↗
MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) RUBBER STRIP WAS FELL 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 23414552 ↗
MalfunctionOct 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) RUBBER (FRONT BODY COIL SEAL ) WAS FELL 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 23348346 ↗
MalfunctionAug 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 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 22923752 ↗
MalfunctionAug 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS COMING 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 LOOSE, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22881900 ↗
MalfunctionJul 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL FELL 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 LOOSE IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22539778 ↗
MalfunctionFeb 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL IS 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 DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21353466 ↗
MalfunctionFeb 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL FELL 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 LOOSE IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21342017 ↗
MalfunctionFeb 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 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 LOOSE IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21342014 ↗
MalfunctionFeb 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 LOOSE, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21342011 ↗
MalfunctionFeb 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QBC SEAL FELL OFF (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 21301402 ↗
MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL FELL 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 BROKEN IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21292062 ↗
MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) RUBBER STRIP IS DAMAGED. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS STRIP IS DAMAGED, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21291476 ↗
MalfunctionJan 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL MAGNET TAPE 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 21283037 ↗
MalfunctionJan 31, 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 21282088 ↗
MalfunctionJan 31, 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 IS LOOSE IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21281378 ↗
MalfunctionJan 31, 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 IS LOOSE IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21281377 ↗
MalfunctionJan 31, 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 21281372 ↗
MalfunctionJan 31, 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 IS LOOSE IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21281371 ↗
MalfunctionJan 31, 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 (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 LOOSE, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21281336 ↗

Device details

UDI-DI	`00884838098312`
Brand	Ingenia
Model	Ingenia 3.0T CX
Catalog no.	782105
Company	Philips Medical Systems Nederland B.V.
Product code	LNH · System, nuclear magnetic resonance imaging
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 15, 2025

Device type (GMDN): Full-body MRI system, superconducting magnet

A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.

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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.

How reports and recalls are matched · Editorial policy · Report an error on this page