CARESTREAM DRX-EVOLUTION PlusRecalls & reported problems
Carestream Health, Inc. · DRX-EVOLUTION PLUS SYSTEM LOSHPD · Class 2
- 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 60889978624263), received between Jan 30, 2026 and Jan 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K091889); they may or may not involve this specific model.
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
- Detachment of Device or Device Component1
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.
MalfunctionJan 30, 2026Detachment of Device or Device Component
ON (B)(6) 2026, CARESTREAM HEALTH INC. (CSH) WAS INFORMED OF AN INCIDENT WHILE USING THE CARESTREAM DRX-EVOLUTION PLUS SYSTEM. THE COLLIMATOR DETACHED FROM THE TUBE MOUNT AFTER AN X-RAY EXAM REMAINING SUSPENDED SOLELY BY ITS CABLE. NO PATIENT OR STAFF INJURIES OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24218943 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K091889. One submission often covers many models, so check the product and lot details in each record.
- Z-0796-2014 · Nov 25, 2013 · TerminatedDRX-Evolution with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube ass
- Z-0797-2014 · Nov 25, 2013 · TerminatedDRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube as
- Z-1877-2013 · Jun 3, 2013 · TerminatedCarestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various an
Other System, x-ray, stationary devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.