MR 7000 Series MR 7700 (REF 782120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884838104112), 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 this device's 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, 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.

Recalls naming this device

1. 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-3313-2026 · Root cause: Software design · Recall details · FDA record ↗

2. 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-3242-2026 · Root cause: Software design · Recall details · FDA record ↗

3. 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-1964-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Dec 3, 2025Class IIOpen, 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 · Recall details · FDA record ↗

5. 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-2214-2025 · Root cause: Device Design · Recall details · FDA record ↗

6. May 13, 2025Class IIOpen, 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 · Recall details · FDA record ↗

7. 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-3202-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. Mar 12, 2024Class IIOpen, Classified

   Patient support table floor plate may be incorrectly installed.

   Z-1588-2024 · Root cause: Process design · Recall details · FDA record ↗

9. Jun 12, 2023Class IIOpen, 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 ↗

10. Jun 12, 2023Class IIOpen, 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 ↗

11. Nov 22, 2022Class IIOpen, 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 problems

Recent adverse event reports

The 4 most recent of 4 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 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 ↗