SEDECAL Radiographic System Challenge XRecalls & reported problems
Sedecal · The CHALLENGEX AP Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08436046002388), received between Jul 13, 2023 and Jul 13, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Unintended Movement1
- Unintended System Motion1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2023Unintended System Motion; Unintended Movement; Unintended System Motion; Unintended Movement
THE OPERATOR WAS EXPOSING THE ARM OF THE CHILDREN ON THE DETECTOR PLACED ON THE TABLETOP. BUT AFTER THE LAST EXPOSURE, THE OPERATOR SAID THE CEILING TUBESTAND CAN'T MOVE. THEY PRESS SEVERAL BUTTONS IN THE CONSOLE IN ORDER TO ACTIVATE THE MOVEMENT. AT ONE MOMENT THEY GRABBED THE HANDLE (WHEEL), AND THE TUBE (VERTICAL AXIS) GOES TO FULL SPEED TOWARD THE TABLE TOP. THE OPERATOR HAD TIME TO CLEAR THE ARM OF THE CHILDREN, BUT HIS HEAD HIT THE CEILING TUBESTAND. NO INJURIES WERE CAUSED. IN THE MEANTIME THE OPERATOR SAID SHE TRIED TO PULL UP THE WHEEL WITHOUT EFFECT, UNTIL SHE RELEASED THE HANDLE (WHEEL), AND THE CEILING TUBESTAND STOPS 3 CM ABOVE TABLETOP/DETECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17315840 ↗
Other System, X-Ray, Stationary devices
- FDR Visionary Suite 566-16130-23Shimadzu Corporation · System, X-Ray, Stationary4 recalls0 reports
- FDR Visionary Suite 566-16130-31Shimadzu Corporation · System, X-Ray, Stationary2 recalls0 reports
- Proteus XRaGE Hualun Medical Systems Co., Ltd · System, x-ray, stationary2 recalls0 reports
- FDR Visionary Suite 566-16130-33Shimadzu Corporation · System, X-Ray, Stationary2 recalls0 reports
- Radiography 7300 C 712037Philips Medical Systems DMC GmbH · System, X-Ray, Stationary1 recall1 death8 reports
- DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · System, x-ray, stationary1 recall8 reports
- DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · System, x-ray, stationary1 recall5 reports
- DRX-Compass X-ray SystemCarestream Health, Inc. · System, x-ray, stationary1 recall2 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page