DigitalDiagnost 712032Recalls & 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.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00884838074514), received between Mar 16, 2023 and Dec 10, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Device Fell” (10 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
Recalls naming this device
- 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 ↗
- Sep 21, 2023Open, Classified
Potential for units suspended on the ceiling to fail and fall.
Z-0273-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Fell10
- Device Handling Problem10
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell
IT WAS REPORTED THAT THE SKYPLATE DETECTOR WAS NOT PASSING CALIBRATION AND WAS GETTING A MESSAGE THAT THE DOSE WAS TOO LOW. 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 23766643 ↗MalfunctionNov 27, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell
IT WAS REPORTED THAT THE SKYPLATE NOT WORKING. 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 23665133 ↗MalfunctionNov 17, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell
IT WAS REPORTED THAT THE DETECTOR IS KNOCKED OFF. 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 23567463 ↗MalfunctionNov 17, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell
IT WAS REPORTED THAT THE DETECTOR HAS BEEN DROPPED AND NOW IT IS LOSING CONNECTION AND TURNING OFF. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23567317 ↗MalfunctionJul 9, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell
IT WAS REPORTED THAT THE SKYPLATE WAS SHOWING ALL RED BLINKING LIGHTS AND HAD BEEN DROPPED A FEW DAYS AGO. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22455335 ↗MalfunctionMay 20, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell
IT WAS REPORTED THAT THE DETECTOR PROTECTION PANEL WAS DAMAGED. THE USE OF DEVICE WAS UNKNOWN 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 22049901 ↗MalfunctionMar 11, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell
IT WAS REPORTED THAT THE IMAGES ARTIFACTS OCCURRED DUE TO BAD CASSETTE. 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 21569576 ↗MalfunctionAug 13, 2024Device Handling Problem; Device Fell; Device Handling Problem; Device Fell
IT WAS REPORTED THAT DETECTOR WAS DAMAGED AFTER IT WAS DROPPED. 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 19970890 ↗MalfunctionNov 21, 2023Device Handling Problem; Device Fell; Device Handling Problem; Device Fell
THE CUSTOMER REPORTED THAT THE PORTABLE DETECTOR HAD SLIPPED OUT OF THE HANDS FROM OPERATOR DURING HANDLING AND WAS NO LONGER WORKING. A DROPPED DETECTOR CAN LEAD IN WORST CASE TO A FRACTURE IN THE FOOT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18181839 ↗MalfunctionMar 16, 2023Device Handling Problem; Device Fell; Device Handling Problem; Device Fell
THE CUSTOMER REPORTED THAT THE DETECTOR WAS DROPPED TO THE FLOOR FROM A GREAT HEIGHT. THE DETECTOR STILL WORKS BUT THEY WANT TO HAVE IT CHECKED. A DROPPED DETECTOR CAN LEAD IN WORST CASE TO A FRACTURE IN THE FOOT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16551241 ↗
Other Solid state x-ray imager (flat panel/digital imager) devices
- SEDECAL SM-40HF-B-D-CSedecal · Solid State X-Ray Imager (Flat Panel/Digital Imager)24 recalls1 report
- SEDECAL SM-40HF-B-D-VIRSedecal · Solid State X-Ray Imager (Flat Panel/Digital Imager)12 recalls1 report
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)7 recalls0 reports
- DigitalDiagnost C90 712034Philips Medical Systems DMC GmbH · Solid state x-ray imager (flat panel/digital imager)3 recalls90 reports
- DigitalDiagnost C90 712035Philips Medical Systems DMC GmbH · Solid state x-ray imager (flat panel/digital imager)4 recalls17 reports
- DigitalDiagnost 712031Philips Medical Systems DMC GmbH · Solid state x-ray imager (flat panel/digital imager)2 recalls65 reports
- NA GM85Samsung Electronics Co., Ltd. · Solid State X-Ray Imager (Flat Panel/Digital Imager)3 recalls4 reports
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)3 recalls0 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 · each recall links to the FDA recall notice
- 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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