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DigitalDiagnost 712031Recalls & reported problems

Philips Medical Systems DMC GmbH · The DigitalDiagnost is a high-end digital radiography system, that includes - Accessory-lead apron for Vertical stand; - Additional SkyPlate charger; - Adjustable Straps for Patient Support; - Compression Belt (singles. pull); - Detector Holder for Patient Bed; - Hand grips (Pair of); - Handle for Skyplate Large; - Infusion bottle holder; - Mobile Detector Holder; - Paper roll holder; - Patient Support for Stitching; - Portable Panel Protector; - Remote control holder; - Set of 50 Hygienic Bags large; - Set of 50 Hygienic Bags small; - Side Bar; - Stretch Grip for VS/VM Stand; - Table top support · Class 2

All models of DigitalDiagnost (4)

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

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Philips DigitalDiagnost is a digital X-ray imaging system. The 65 reports mostly describe detectors being dropped or knocked and parts breaking off or detaching, with no deaths and no injuries. There are 2 open recalls, one about ceiling-mounted units that could fail and fall and one about ceiling carriages that are hard to move vertically. Reports dropped to 11 in the last 12 months from 35 the year before.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
65
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00884838065321), received between Jul 11, 2019 and Jun 30, 2026 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Device Fell” (54 reports).

2 FDA recall records name this device's identifier, 2 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 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 3 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 2 reportsAug 2024: 2 reportsSep 2024: 1 reportsOct 2024: 2 reportsNov 2024: 3 reportsDec 2024: 2 reportsJan 2025: 6 reportsFeb 2025: 4 reportsMar 2025: 4 reportsApr 2025: 1 reportsMay 2025: 5 reportsJun 2025: 2 reportsJul 2025: 4 reportsAug 2025: 2 reportsSep 2025: 1 reportsOct 2025: 1 reportsNov 2025: 4 reportsDec 2025: 4 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 2 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520266
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Oct 1, 2025Open, Classified

    Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.

    Z-0464-2026 · Root cause: Device Design · Recall details · FDA record ↗

  2. Sep 21, 2023Open, Classified

    Potential for units suspended on the ceiling to fail and fall.

    Z-0274-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

  • Device Fell54
  • Device Handling Problem53
  • Detachment of Device or Device Component5
  • Poor Quality Image4
  • Fire2
  • Electrical /Electronic Property Problem1
  • Inappropriate/Inadequate Shock/Stimulation1
  • Power Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions64
  • Shock1

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 30, 2026Detachment of Device or Device Component

    IT WAS REPORTED THAT THE PATIENT STEP PLATE ON THE ENTIRE TRIPOD HAD BROKEN OFF AT THE BACK. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO HARM TO THE PATIENT OR USER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25663720 ↗
  • MalfunctionJun 5, 2026Fire

    IT WAS REPORTED THAT A FIRE INCIDENT HAD OCCURRED WITHIN THE HOSPITAL FACILITY OVER THE WEEKEND. AS A RESULT OF THE INCIDENT, SMOKE ENTERED THE ROOM WHERE THE PHILIPS SYSTEM WAS INSTALLED THROUGH CABLE DUCTS CONNECTED TO ADJACENT AREAS. AS A PRECAUTIONARY MEASURE, THE CUSTOMER DISCONNECTED THE ACQUISITION WORKSTATION (AWS) AND REQUESTED VERIFICATION OF SYSTEM FUNCTIONALITY BEFORE RETURNING THE EQUIPMENT TO SERVICE. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE EVENT, AND NO PATIENT OR USER HARM WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25410919 ↗
  • MalfunctionMar 2, 2026Detachment of Device or Device Component

    IT WAS REPORTED THAT THE PATIENT SUPPORT PROBLEM. THE DEVICE WAS NOT IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24481127 ↗
  • MalfunctionDec 16, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE REMOTE ALERT OF A MECHANICAL HEAVY SHOCK TO THE DETECTOR. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO HARM TO PATIENT OR USER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23818701 ↗
  • MalfunctionDec 16, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE REMOTE ALERT OF A HEAVY SHOCK TO THE DETECTOR. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO HARM TO PATIENT OR USER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23818691 ↗
  • MalfunctionDec 15, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE DETECTOR WAS DROPPED AND NOW IT WILL NOT CALIBRATE. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23800128 ↗
  • MalfunctionDec 9, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE LARGE MOBILE DETECTOR FAILED, AND UNDERTABLE MOUNTING WAS NOT POSSIBLE. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23756851 ↗
  • MalfunctionNov 26, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE ON-SWITCH OF THE DIGITAL DETECTOR CAN NO LONGER BE OPERATED PROPERLY. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23655170 ↗
  • MalfunctionNov 25, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE SKYPLATE WAS DROPPED AND NOW FACING ISSUES. THE DEVICE WAS NOT IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23646201 ↗
  • MalfunctionNov 21, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE REMOTE ALERT OF A MECHANICAL HEAVY SHOCK TO THE DETECTOR. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO HARM TO PATIENT OR USER. ADDITIONAL INFORMATION RECEIVED THAT THE DETECTOR HAD BEEN DROPPED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23615275 ↗
  • MalfunctionNov 18, 2025Power Problem; Power Problem

    IT WAS REPORTED THAT GENERATOR ERROR OBSERVED AFTER A POWER OUTAGE. THE USE OF DEVICE WAS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23583422 ↗
  • MalfunctionOct 28, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    EVENT DESCRIPTION: IT WAS REPORTED THAT THE SKYPLATE WAS DROPPED AND IS NOT WORKING; NO IMAGE. THE DEVICE WAS NOT IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23404200 ↗
  • MalfunctionSep 15, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE DETECTOR DROPPED. THE USE OF DEVICE WAS UNKNOWN AND THERE WAS NO PATIENT OR USER HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23049417 ↗
  • MalfunctionAug 14, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT ARTIFACTS APPEARED ON THE DETECTOR DURING EXPOSURE. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22805533 ↗
  • MalfunctionAug 8, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE DETECTOR WAS DROPPED, RESULTING IN A MASSIVE ARTIFACT THAT COMPLETELY BLOCKS ANY IMAGE TAKEN. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22746905 ↗
  • MalfunctionJul 29, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE DETECTOR HAS ARTIFACT DUE TO DETECTOR DROP. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22645350 ↗
  • MalfunctionJul 22, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE REMOTE ALERT OF A MECHANICAL HEAVY SHOCK TO THE DETECTOR. THE DEVICE WAS OUTSIDE OF CLINICAL USE AND THERE WAS NO HARM TO PATIENT OR USER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22565342 ↗
  • MalfunctionJul 21, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE LINES ON THE IMAGES OF THE SKYPLATE DETECTOR. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM. ADDITIONAL INFORMATION RECEIVED THAT THE DETECTOR WAS DROPPED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22555875 ↗
  • MalfunctionJul 7, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE DROPPED PLATE HAS A GRID LINE. THE DEVICE WAS NOT IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22410659 ↗
  • MalfunctionJun 26, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT WHITE STRIPES ON DETECTOR. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM. ADDITIONAL INFORMATION RECEIVED THAT THE DETETCOR WAS DROPPED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22334875 ↗
  • MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE HYDRAULICS OF THE PLATFORM OF THE COLUMN CART FAIL. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM. ADDITIONAL INFORMATION RECEIVED THAT THE HYDRAULIC FAILURE WAS CAUSED BY A DEFECTIVE GAS SPRING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22222837 ↗
  • MalfunctionMay 25, 2025Fire; Fire

    IT WAS REPORTED THAT THE MACHINE IS NOT SWITCHING ON WHILE TRIES TO DIAGNOSIS CONTROLLER BOARD GETS SHORT AND STARTS FIRE. THE DEVICE WAS OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22082479 ↗
  • MalfunctionMay 22, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE REMOTE ALERT OF HEAVY SHOCK TO 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 22068679 ↗
  • MalfunctionMay 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE PATIENT SUPPORT IS BROKEN. THE USE OF THE DEVICE WAS UNKNOWN AND THERE WAS NO HARM TO THE PATIENT OR USER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22042568 ↗
  • MalfunctionMay 12, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

    IT WAS REPORTED THAT THE DETECTOR WAS DROPPED AND LEADING TO ARTIFACT ON RIGHT SIDE OF EXPOSURES. THE DEVICE WAS NOT IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22000725 ↗

Other Solid state x-ray imager (flat panel/digital imager) devices

All Solid state x-ray imager (flat panel/digital imager) devices →

Sources and updates

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