DRX-Evolution Plus SystemRecalls & reported problems
Carestream Health, Inc. · DRX-Evolution Plus Automatic - Dual Buck · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 60889971739193), received between Sep 13, 2023 and Mar 6, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Radiation Overexposure” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Radiation Overexposure3
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.
MalfunctionMar 6, 2024Radiation Overexposure; Radiation Overexposure
ON (B)(6) 2024, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-EVOLUTION SYSTEM THAT OCCURRED ON (B)(6) 2024. THE PROBLEM DESCRIPTION OUTLINES A RADIATION DOSE HIGHER THAN EXPECTED. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18852528 ↗MalfunctionJan 4, 2024Radiation Overexposure; Radiation Overexposure
ON 07-DEC-2023, CARESTREAM HEALTH (CSH) WAS NOTIFIED BY THE HEALTH PRODUCTS REGULATORY AUTHORITY (HPRA) IN (B)(6) OF A USER FACILITY REPORT REF: (B)(4). THE REPORT INFORMED OF AN INCIDENT RELATED TO THE DRX-EVOLUTION SYSTEM THAT OCCURRED ON (B)(6) 2023. THE REPORT OUTLINES A RADIATION DOSE HIGHER THAN EXPECTED. NO INJURIES WERE REPORTED. THERE HAVE BEEN NO OTHER REPORTS OF THIS TYPE FROM OTHER CUSTOMERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18449444 ↗InjurySep 13, 2023Radiation Overexposure; Radiation Overexposure
ON (B)(6) 2023, THE BUSINESS PARTNER (BP) MEDRAY, INFORMED CARESTREAM HEALTH THAT A SITE EXPOSED A PATIENT MORE THAN 10X THE EXPECTED DOSE. EXPECTED DOSE: 100 KV, 28MAS. GIVEN DOSE: 100 KV, 353.2MAS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17736223 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.