MR 5000 SeriesRecalls & reported problems across all models
Philips Medical Systems Nederland B.V. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
8 open recalls name at least one MR 5000 Series model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 8
We found 3 models of MR 5000 Series by Philips Medical Systems Nederland B.V. in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Aug 20, 2024 and Jul 3, 2026 — classified as 11 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (11 reports).
8 FDA recall records name at least one of these models by its device 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. 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 5000 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-3312-2026 · Root cause: Software design · names 3 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-3241-2026 · Root cause: Software design · 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-2213-2025 · 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-1804-2025 · 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-3201-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 3, 2024Open, 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, 2024Open, 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, 2024Open, Classified
Patient support table floor plate may be incorrectly installed.
Z-1587-2024 · Root cause: Process design · Recall details · FDA record ↗
Most reported MR 5000 Series problems
Device problems
- Improper or Incorrect Procedure or Method11
- Insufficient Device Problem Information8
Patient problems
- Partial thickness (Second Degree) Burn11
- Burn(s)1
- Full thickness (Third Degree) Burn1
MR 5000 Series models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MR 5000 Series MR 5300System, nuclear magnetic resonance imaging8 recalls9 reports
- MR 5000 Series MR 5300System, Nuclear Magnetic Resonance Imaging3 recalls2 reports
- MR 5000 Series MR 5300System, Nuclear Magnetic Resonance Imaging1 recall0 reports
Recent MR 5000 Series adverse event reports
The 11 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗
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
- MR 7000 Series2 models · 4 reports · 11 recalls
- Dynamic Coronary Roadmap3 models · 10 reports · 9 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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