ProGrade 9897-010-01041Recalls & reported problems
Philips Medical Systems DMC GmbH · Solid State X-Ray Imager (Flat Panel/Digital Imager) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838074538), received between Nov 22, 2024 and Nov 5, 2025 — classified as 3 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
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell
IT WAS REPORTED THAT THE SYSTEM DID NOT GIVE THE PRE-GREEN LIGHT TO CAPTURE IMAGES, WHILE THE OTHER TWO LIGHTS WERE RED. THE DEVICE WAS IN CLINICAL USE AT THE TIME, AND THERE WAS NO HARM TO THE PATIENT OR THE USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23473918 ↗MalfunctionMar 3, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell
IT WAS REPORTED THAT THE DETECTOR WAS DROPPED AND IT WAS NOT WORKING. THE USE OF DEVICE WAS UNKNOWN AND THERE WAS NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21503099 ↗MalfunctionNov 22, 2024Device Handling Problem; Device Fell; Device Handling Problem; Device Fell
THE CUSTOMER REPORTED THAT THE DETECTOR KEPT RANDOMLY TURNING OFF AND THAT THE PORTABLE DETECTOR WAS DROPPED. THE DEVICE WAS NOT IN CLINICAL USE AND THERE WAS NO PATIENT OR USER IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20758800 ↗
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
- 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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