MR 5000 Series MR 5300 (REF 782152)Recalls & reported problems
Philips Medical Systems Nederland B.V. · Philips innovative MR 5300 magnetic resonance imaging system simplifies and automates the most complex clinical and operational tasks. So you can create highly personalized exams of even your most challenging patients. Quickly. Easily. Intelligently. Smart Workflow reduces the number of steps needed to complete an MR exam and enables guided patient set-up in under a minute, the ultra-lightweight and flexible Breeze coils help cut patient change-over time by 30% to keep your MR department on schedule. At the same time, they improve patient comfort and staff satisfaction. This will help you meeting the challenging demands of productivity and patient throughput at private clinics and diagnostic imaging centers. MR 5300 is not only a fast MR, but also smart and flexible, providing intelligent tools for fast exams and quality scanning. · Class 2
All models of MR 5000 Series (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838112841), received between Mar 21, 2025 and Feb 6, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).
3 FDA recall records name this device's identifier, 3 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-3312-2026 · 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-2213-2025 · 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-1804-2025 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method2
- Insufficient Device Problem Information2
Patient problems
- Partial thickness (Second Degree) Burn2
Recent adverse event reports
The 2 most recent of 2 reports, 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 DEVELOPED A BURN/BLISTER ON THE RIGHT FOREARM, DURING CERVICAL AND LUMBAR SPINE EXAM. THE BLISTER SIZE IS REPORTED AS 15 CM LONG. THE PATIENT WAS EXAMINED BY THE NURSE AND COOLING WAS APPLIED. IT IS REPORTED, IT IS UNKNOWN IF THE INJURY WILL HEAL COMPLETELY.THE REPORTED INJURY MEETS THE CRITERIA FOR A SERIOUS INJURY.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 24275510 ↗InjuryMar 21, 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 EXPERIENCED A HEATING SENSATION, SKIN REDDENING, AND BLISTERING DURING LEFT AXILLARY SOFTNESS TISSUE EXAMINATION. THE BURN WAS REPORTED AS A 2ND DEGREE 10 CM SIZED AREA ON THE RIGHT LATERAL UPPER ARM AREA. THREE DIGITAL PHOTOS WERE RECEIVED FOR REVIEW. IN ONE, THERE IS AN AREA WHICH SHOWS THE REPORTED BLISTERING IN MULTIPLE AREAS AND ERYTHEMA. THE OTHER TWO PHOTOS SHOW THE WOUND IN VARIOUS STAGES OF HEALING. IT IS REPORTED THE INJURY IS EXPECTED TO SCAR. IT WAS REPORTED THERE WAS NO MEDICAL INTERVENTION PERFORMED.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 21665576 ↗
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- Ingenia Ingenia 3.0T CXPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging11 recalls59 reports
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- Ingenia Ingenia Elition XPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging11 recalls5 reports
- MR 7000 Series MR 7700Philips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging11 recalls4 reports
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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