MR 7000 SeriesRecalls & reported problems across all models
Philips Medical Systems Nederland B.V. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
11 open recalls name at least one MR 7000 Series model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 11
We found 2 models of MR 7000 Series by Philips Medical Systems Nederland B.V. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Jan 30, 2023 and Feb 6, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).
11 FDA recall records name at least one of these models by its device identifier, 11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
MR 7000 Series recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 28, 2026Open, 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-3313-2026 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗
- Aug 21, 2026Open, 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-3242-2026 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗
- Apr 14, 2026Open, 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-1964-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Dec 3, 2025Open, Classified
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Z-1213-2026 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗
- Jun 30, 2025Open, 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-2214-2025 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
- May 13, 2025Open, Classified
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Z-1805-2025 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗
- Sep 3, 2024Open, 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-3202-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 12, 2024Open, Classified
Patient support table floor plate may be incorrectly installed.
Z-1588-2024 · Root cause: Process design · Recall details · FDA record ↗
- Jun 12, 2023Open, Classified
During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.
Z-2400-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 12, 2023Open, Classified
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
Z-2397-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 22, 2022Open, Classified
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Z-0462-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported MR 7000 Series problems
Device problems
- Insufficient Device Problem Information4
- Improper or Incorrect Procedure or Method2
- Activation Failure1
- Detachment of Device or Device Component1
Patient problems
- Full thickness (Third Degree) Burn2
- No Clinical Signs, Symptoms or Conditions2
- Partial thickness (Second Degree) Burn1
MR 7000 Series models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MR 7000 Series MR 7700System, nuclear magnetic resonance imaging11 recalls4 reports
- MR 7000 Series MR 7700System, Nuclear Magnetic Resonance Imaging6 recalls0 reports
Recent MR 7000 Series adverse event reports
The 4 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2026Improper or Incorrect Procedure or Method; Insufficient Device Problem Information
PHILIPS RECEIVED A REPORT THAT THE PATIENT FELT A HEATING SENSATION AND EXPERIENCED SKIN REDDENING AND BLISTERING ON THE RIGHT UPPER SHOULDER CLAVICLE AREA; A 4X4CM CIRCULAR BURN OVERLYING RIGHT CORACOID PROCESS. BURN CONSISTS OF 2X2CM CENTRAL COMPONENT WITH SURROUNDING AREA OF ERYTHEMA. SENSATION IS INTACT IN AREA INVOLVING THE BURN AND IT IS NOT PARTICULARLY TENDER TO TOUCH, THE AFFECTED SIZE OF THE BLISTER IS REPORTED TO BE 4 CM. MEDICAL TREATMENT BY THE WARD DOCTOR AND PLASTIC SURGEON WAS GIVEN. THE REPORTED INJURY MEETS THE CRITERIA FOR A SERIOUS INJURY.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 24275511 ↗InjuryMar 19, 2025Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information
PHILIPS RECEIVED A REPORT THAT THE PATIENT SUSTAINED A BURN TO THE LEFT INNER FOREARM, REPORTED AS A 2ND DEGREE BURN APPROXIMATELY 6 CM IN SIZE. BLISTERING AND A HEATING SENSATION WERE REPORTED DURING A BREAST MRI. MEDICAL TREATMENT PROVIDED TO THE WOUND WAS BIAFINE. THE DIGITAL PHOTO PROVIDED SHOWS THE LEFT FOREARM WITH THE REPORTED WOULD, CIRCULAR IN SHAPE WITH A WHITE CENTER. THE BURN APPEARS TO BE THROUGH THE DERMIS LAYER OF THE PATIENT'S SKIN.
Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn
MAUDE report 21640834 ↗MalfunctionAug 25, 2023Insufficient Device Problem Information; Activation Failure; Insufficient Device Problem Information; Activation Failure
PHILIPS RECEIVED A REPORT OF A GRADIENT COIL FAILURE LEADING TO BURNING SMELL AND VISUAL DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17621953 ↗MalfunctionJan 30, 2023Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
PHILIPS RECEIVED A REPORT OF A FAILING GRADIENT COIL, CAUSING A BURNING SMELL AND TRIPPING THE SMOKE DETECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16264585 ↗
Other Philips Medical Systems Nederland B.V. products
- Allura Xper FD19 models · 15,187 reports · 84 recalls
- Azurion22 models · 9,199 reports · 71 recalls
- Ingenia54 models · 479 reports · 138 recalls
- IntelliSpace Cardiovascular11 models · 439 reports · 3 recalls
- Dynamic Coronary Roadmap3 models · 10 reports · 9 recalls
- MR 5000 Series3 models · 11 reports · 8 recalls
- Brilliance iCT2 models · 9 reports · 8 recalls
- Zenition2 models · 101 reports · 5 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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