Skip to content

Radiography 7000 M 712010Recalls & reported problems

Philips Medical Systems DMC GmbH · Radiography 7000 M digital mobile is a new motorized mobile x-ray system that includes: 1. Base Unit ( Sedecal Mobile X-ray system - SM-IV, cleared under K232185 August 21, 2023) 2. SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories 3. Eleva WorkSpot In addition, the following accessories can be used together with the system - Raidography 7000 M: - Detector Holder f. Patient Bed - Grid Landsc. SkyPlateE Large - Grid Landscape SkyPlate Large - Grid Portr. SkyPlate E Large - Grid Portrait SkyPlate Large - Grid Portrait SkyPlate Small - Handle for Skyplate Large - Portable Panel Protector - Wireless Detect. Mobile Holder - Set of 50 WPD Hygienic Bags (large) - Set of 50 WPD Hygienic Bags (small) · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
8
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884838115521), received between Mar 14, 2025 and Sep 29, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Fell” (3 reports).

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 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 2 reportsApr 2025: 1 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 2 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Fell3
  • Device Handling Problem3
  • Unintended System Motion3
  • Device Dislodged or Dislocated1
  • Mechanical Jam1

Patient problems

  • No Clinical Signs, Symptoms or Conditions8

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 29, 2026Unintended System Motion

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50929310 ↗
  • MalfunctionSep 24, 2026Unintended System Motion

    It was reported that the system stopped driving after completion of a patient examination. After rebooting the system, it would only drive in reverse at full speed. The device was out of clinical use, and there was no patient or user harmed.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50880337 ↗
  • MalfunctionAug 11, 2026Mechanical Jam

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50206812 ↗
  • MalfunctionOct 24, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE PROBLEM WITH SKYPLATE. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23376415 ↗
  • MalfunctionMay 6, 2025Unintended System Motion; Unintended System Motion

    IT WAS REPORTED THAT THE SYSTEM IS LOADED ON ELEVATOR IN REVERSE BY TECHNICIAN. WHEN THE TECHNICIAN RELEASES THE DRIVE HANDLE SYSTEM DOES NOT STOP. INTERMITTENT ISSUE THAT HAS BEEN DESCRIBED BY TECHNICIANS AND FIELD SERVICE ENGINEER (FSE) DUPLICATED ONCE WITH LEFT WHEEL CONTINUING TO DRIVE IN REVERSE FOR 1.5 SECONDS AFTER HANDLE WAS RELEASED BY FSE. THE DEVICE WAS NOT IN CLINICAL USE AND THERE WAS NO HARM TO PATIENT OR USER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21966212 ↗
  • MalfunctionApr 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT WHILE REVERSING THE SYSTEM INTO THE ELEVATOR, A RELEASE OF THE HANDLE OCCURRED TO PRESS THE BUTTON, CAUSING BACKWARD MOVEMENT OF ABOUT A FOOT WITH A RIGHTWARD TURN. NO CONTACT WITH THE HANDLE WAS MAINTAINED DURING THAT TIME. THE DEVICE USE IS UNKNOWN AND THERE WAS NO HARM TO PATIENT OR USER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21917393 ↗
  • MalfunctionMar 18, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE DETECTOR WAS NOT LINKING TO THE SYSTEM AND THERE WAS AN AVERAGE IMPACT ON THE PORTABLE DETECTOR. NO HARM WAS REPORTED. UPON FOLLOW UP, ADDITIONAL INFORMATION RECEIVED CONFIRMING THAT THE DETECTOR WAS DROPPED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21632692 ↗
  • MalfunctionMar 14, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE HEAVY MECHANICAL SHOCK WAS RECORDED ON THE DETECTOR. THE DEVICE WAS NOT IN CLINICAL USE AND THERE WAS NO HARM TO PATIENT OR USER. ADDITIONAL INFORMATION RECEIVED THAT THE DETECTOR WAS DROPPED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21606386 ↗

Other System, X-Ray, Mobile devices

All System, X-Ray, Mobile devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page