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
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
- Philips MobileDiagnost wDR 2.2Sedecal · System, X-Ray, Mobile3 recalls7 reports
- DRX-Revolution Mobile X-ray SystemCarestream Health, Inc. · System, x-ray, mobile2 recalls12 reports
- Optima XR200amxGE Medical Systems, L.L.C. · System, x-ray, mobile2 recalls1 report
- Optima XR220amxGE Medical Systems, L.L.C. · System, x-ray, mobile2 recalls0 reports
- Optima XR240amxGE Medical Systems, L.L.C. · System, x-ray, mobile2 recalls0 reports
- DRX-Revolution Mobile X-ray SystemCarestream Health, Inc. · System, x-ray, mobile1 recall16 reports
- SEDECAL Soltus 500Sedecal · System, X-Ray, Mobile1 recall4 reports
- MobileDaRt Evolution 503-79999-01Shimadzu Corporation · System, X-Ray, Mobile1 recall0 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
- 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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