MR 5000 Series MR 5300 (REF 782110)Recalls & reported problems
Philips Medical Systems Nederland B.V. · This innovative magnetic resonance imaging system MR 5300 is powered by Philips exclusive BlueSeal magnet for helium-free operations. While its AI-driven technology simplifies and automates the most complex clinical and operational tasks, so you can focus on what matters most: your patients. • Smart Workflow dramatically reduces the number of steps needed to complete an MR exam – with guided patient set-up in under a minute, touchless patient sensing, and single-click initiation of routine exams. And the industry’s lightest 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. • Compressed SENSE accelerates MR scans by up to 50% with virtually no loss of image quality to increase diagnostic confidence. And the system’s BlueSeal magnet securely isolates the small amount of liquid helium needed for cooling inside the bore. There’s no helium loss, no refills, and no unexpected costs. • Philips Performance for Life solutions add remote serviceability, AI-enabled predictive maintenance, frequent system updates, and perpetual coil replacement. All helping you to improve uptime and manage your total cost of ownership. Discover the system that transforms MR imaging with fully automated patient-centric workflow, ultra-fast exams, high quality diagnostic outcomes, and performance for life. Make the smart choice – Philips MR 5300. · Class 2
All models of MR 5000 Series (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
8 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 8
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884838099364), received between Aug 20, 2024 and Jul 3, 2026 — classified as 9 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (9 reports).
8 FDA recall records name this device's identifier, 8 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 ↗
- 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-3241-2026 · 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 ↗
- 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-3201-2024 · 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-1855-2024 · 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-1854-2024 · 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-1587-2024 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method9
- Insufficient Device Problem Information6
Patient problems
- Partial thickness (Second Degree) Burn9
- Burn(s)1
- Full thickness (Third Degree) Burn1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2026Improper or Incorrect Procedure or Method
PHILIPS RECEIVED A REPORT THAT THE PATIENT EXPERIENCED BURN, BLISTERING ON THE UPPER RIGHT ARM DURING A SHOULDER SCAN. THE PATIENT UNDERWENT THE EXAM IN THE HEAD FIRST SUPINE. THE PATIENT PRESSED THE NURSE CALL BUTTON DURING THE EXAM TO REPORT A HEATING SENSATION IN THE AREA OF THE UPPER RIGHT ARM. THE PATIENT WAS POSITIONED OFF-CENTER. THE PATIENT WORE THEIR OWN CLOTHING WHICH WAS REPORTED TO BE DRY, MADE UP OF MICROFIBERS. IT IS REPORTED THE COIL USED FOR THE EXAM WAS THE MSK M AND MSK S COILS. THE AREA ON THE UPPER RIGHT ARM IS SHOWN OBLONG IN SHAPE AND APPEARS TO HAVE SEVERAL BLISTERS INSIDE A REDDENED AREA. THE LARGEST BLISTER IS APPROXIMATELY 3 CM. THE REPORTED INJURY MEETS THE CRITERIA FOR A SERIOUS INJURY DUE TO THE BLISTER SIZE AND REPORTED MEDICAL TREATMENT PROVIDED BY THE DERMATOLOGIST.
Patient problems: Burn(s); Partial thickness (Second Degree) Burn
MAUDE report 25701905 ↗InjuryApr 2, 2026Improper or Incorrect Procedure or Method
PHILIPS RECEIVED A REPORT THAT THE PATIENT EXPERIENCED THE BURN, WHILE UNDERGOING A BRAIN AND SPINE/NECK MRI SCAN WITH CONTRAST. THE EXAM WAS A LONG DURATION APPROXIMATELY 90 MINUTES WITH THE PATIENT SEDATED. PER THE DIAGRAM ON THE HEATING QUESTIONNAIRE, THE PATIENT 'S RIGHT FOREARM AND AREA HAD AN AREA OF BLISTERING. THE BURN DEPTH OR DEGREE IS REPORTED AS "1". THE BURN EMERGED SHORTLY AFTER THE EXAM. IT IS UNKNOWN IF THE BURN WILL HEAL COMPLETELY. LOCAL TOPICAL TREATMENT WAS PERFORMED, THIS WAS NOT SPECIFIED. A DIGITAL PHOTO WAS RECEIVED FOR REVIEW. THE PATIENT'S RIGHT ARM IS SHOWN WITH A LARGE AREA OF RAISED LINEAR SHAPED SWELLING WHICH APPEAR TO BE A DEVELOPING BLISTER. THE AREA EXTENDS FROM THE PATIENT'S ELBOW DOWN PAST THE FOREARM. THE SKIN APPEARS INTACT AT THE TIME THE PHOTO WAS TAKEN. THE SIZE OF THE BLISTER MEETS THE CRITERIA FOR A SERIOUS INJURY. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 24764970 ↗InjuryFeb 11, 2026Improper or Incorrect Procedure or Method; Insufficient Device Problem Information
PHILIPS RECEIVED A REPORT THAT THE PATIENT EXPERIENCED SKIN REDDENING AND BLISTERING ON THE RIGHT SIDE OF THE LEFT THUMB. THERE IS A SCAB REPORTED TO BE 1 CM X 1 CM. THE BURN APPEARED MORE THAN ONE HOUR AFTER THE EXAM. THE PATIENT REPORTED THE BURN 28 DAYS AFTER THE EXAMINATION. THE PATIENT DID NOT UNDERGO MEDICAL TREATMENT. THE REPORTED INJURY TO THE PATIENT'S HAND MEETS THE CRITERIA FOR A SERIOUS INJURY.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 24312932 ↗InjuryJul 29, 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, DURING A CERVICAL VERTEBRAE EXAM IN THE HEAD-FIRST SUPINE POSITION, THE PATIENT EXPERIENCED A BURN WITH A BLISTER, SKIN REDDENING, AND A HEATING SENSATION ON THE RIGHT UPPER ARM. THE SIZE OF THE REPORTED BLISTER AREA WAS 6 X 1.5 CM. IT WAS REPORTED THAT THE MOISTURIZING CREAM FLAMAZINE WAS APPLIED. THE BURN DEPTH WAS DESCRIBED AS SECOND-DEGREE. THE PATIENT WAS WEARING HOSPITAL-SUPPLIED CLOTHING, WHICH WAS DESCRIBED AS DRY. NO PADDING WAS USED. IT WAS REPORTED THAT THE CABLE WAS IN CONTACT WITH THE SKIN. THE REPORTED HEATING INCIDENT MEETS THE CRITERIA FOR A SERIOUS INJURY.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 22643558 ↗InjuryFeb 18, 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 WIT THE BLISTER TO THE UPPER RIGHT ARM AND A PROVIDED PICTURE REVEALED A BLISTER THAT EXCEEDS 2.5CM WITH REDDENING OF THE SKIN SURROUNDING THE BLISTER. THE PATIENT WAS PROVIDED WITH COOLING AND DISINFECTION OF THE BURN AND IT WAS STATED IT WAS UNKNOWN IF THE PATIENT WILL FULLY RECOVER.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 21402271 ↗InjuryFeb 18, 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 RIGHT UPPER ARM WITH REDDENING OF THE SKIN AND BLISTERING. ADDITIONALLY, A PICTURE PROVIDED SHOWS A BLISTER THAT APPEARS LARGER THAN 2.5 CM, ALTHOUGH MEASUREMENTS OF THE BLISTER WERE NOT PROVIDED. THE PATIENT WAS PROVIDED COOLING AND TOPICAL OINTMENT AND IS EXPECTED TO FULLY RECOVER.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 21392739 ↗InjuryJan 24, 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 SUFFERED A BURN TO THE RIGHT LOWER FOREARM WITH BLISTERING. IT WAS REPORTED THAT DURING THE EXAM THE PATIENT FELT WARM AND THE BLANKET WAS REMOVED FROM THE PATIENT. THE TOTAL BURN SIZE WAS REPORTED TO BE 10CM BUT THE BLISTER SIZE WAS NOT DEFINED. THE PATIENT WAS GIVEN A TOPICAL ZINC OXIDE CREAM AND IS EXPECTED TO FULLY RECOVER.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 21228090 ↗InjuryJan 14, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
PHILIPS RECEIVED A REPORT THAT THE PATIENT SUFFERED A BURN WITH A BLISTER MEASURING 5 CM TO THE LEFT LEG IN THE AREA OF THE KNEE DURING AN EXAM. THE PATIENT PRESSED THE NURSE CALL LIGHT FOR A HEATING SENSATION DURING THE EXAM, WAS GIVEN A DERMATOLOGY REFERRAL, AND IS EXPECTED TO FULLY RECOVER. IT IS UNKNOWN WHAT MEDICAL TREATMENT WAS PROVIDED BY DERMATOLOGY. COMPLAINT DETAILS INDICATE A SECOND DEGREE BURN WITH A BLISTER >2.5 CM OCCURRED AS ASSESSED FROM THE PICTURES PROVIDED.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 21147368 ↗InjuryAug 20, 2024Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information
PHILIPS RECEIVED A REPORT THAT A FEMALE PATIENT SUFFERED 2ND DEGREE BURN TO THE RIGHT ELBOW WITH BLISTERING DURING LUMBAR AND PELVIC REGION EXAM WITH DS TORSO CARDIAC COIL.
Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn
MAUDE report 20006452 ↗
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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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