DRX - Ascend SystemRecalls & reported problems
Carestream Health, Inc. · DRX-ASCEND SYSTEM/QG-65-R10-T140 · Class 2
Data updated Oct 13, 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 60889971023148), received between Nov 17, 2022 and Nov 17, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Radiation Overexposure” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Radiation Overexposure1
Patient problems
- Insufficient Information1
- 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.
MalfunctionNov 17, 2022Radiation Overexposure; Radiation Overexposure
ON 19-OCT-22, CARESTREAM HEALTH (CSH) WAS NOTIFIED OF AN INCIDENT RELATED TO THE DRX ASCEND SYSTEM: THE GENERATOR DID NOT ABORT AFTER ERROR (ER51) AND CONTINUED THE EXPOSURE. THERE HAS BEEN NO INJURY REPORTED. CSH INVESTIGATION IS CURRENTLY IN PROGRESS. SUBMITTING AN INITIAL REPORT TO THE US FDA AS THERE ARE CURRENTLY INSUFFICIENT FACTS AVAILABLE TO MAKE A REPORTABILITY DECISION AND AT LEAST 25 DAYS HAS ELAPSED. UDI NUMBER AND MANUFACTURING DATE ARE NOT AVAILABLE AT TIME OF THIS REPORT, WILL UPDATE FOLLOW UP REPORT WITH UDI NUMBER AND MANUFACTURING DATE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15813875 ↗
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
- FDR Visionary Suite 566-16130-33Shimadzu Corporation · System, X-Ray, Stationary2 recalls0 reports
- Proteus XRaGE Hualun Medical Systems Co., Ltd · System, x-ray, stationary2 recalls0 reports
- DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · System, x-ray, stationary1 recall8 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 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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