DRX-Revolution Mobile X-ray SystemRecalls & reported problems across all models
Carestream Health, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one DRX-Revolution Mobile X-ray System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls
- 2
We found 2 models of DRX-Revolution Mobile X-ray System by Carestream Health, Inc. in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Oct 21, 2020 and Nov 27, 2025 — classified as 19 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (11 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
DRX-Revolution Mobile X-ray System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 2, 2023Open, Classified
There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained thermal overload within the generator. Should an event like this occur, the system will become inoperable and loud noise, burnt smell and smoke may be detectable.
Z-0289-2024 · Root cause: Component design/selection · names 2 of these models · Recall details · FDA record ↗
- Oct 2, 2023Open, Classified
Unexpected failure of electrical components within the CPI generator.
Z-0437-2024 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported DRX-Revolution Mobile X-ray System problems
Device problems
- Unintended Movement11
- Improper or Incorrect Procedure or Method6
- Smoking5
- Sparking2
- Thermal Decomposition of Device2
- Detachment of Device or Device Component1
- Device Displays Incorrect Message1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Bone Fracture(s)6
- Insufficient Information4
- Pain3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Bruise/Contusion1
- Burn(s)1
- Chemical Exposure1
DRX-Revolution Mobile X-ray System models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DRX-Revolution Mobile X-ray SystemSystem, x-ray, mobile2 recalls12 reports
- DRX-Revolution Mobile X-ray SystemSystem, x-ray, mobile1 recall16 reports
Recent DRX-Revolution Mobile X-ray System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON 29-OCT-2025, CARESTREAM HEALTH (CSH) WAS INFORMED OF A MECHANICAL ISSUE WHILE USING THE DRX-REVOLUTION MOBILE X-RAY SYSTEM. NO INJURIES REPORTED, THE INVESTIGATION IS ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23667674 ↗MalfunctionMay 23, 2024Unintended Movement; Unintended Movement
ON (B)(6) 2024, CARESTREAM HEALTH (CSH) WAS INFORMED OF WAS INFORMED OF AN UNINTENDED MOVEMENT WHILE USING THE DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM. NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19381839 ↗InjuryMay 12, 2024Smoking; Smoking
ON (B)(6) 2024, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM. THE PLUG ON THE POWER CORD WAS SMOKING WHEN UNPLUGGING THE UNIT FROM AN ELECTRICAL WALL OUTLET RESULTING IN THE TECH TO BURN HER THUMB. NO PATIENT INVOLVEMENT.
Patient problems: Burn(s)
MAUDE report 19295803 ↗InjuryApr 25, 2024Sparking; Sparking
ON 25-MAR-2024, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM. THE UNIT SPARKED WHEN PLUGGING THE UNIT INTO THE WALL RESULTING IN THE TECH TO BE SHOCKED. THE STATE OF INJURY IS UNKNOWN. NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ONGOING.
Patient problems: Insufficient Information
MAUDE report 19180541 ↗InjuryMar 14, 2024Unintended Movement; Unintended Movement
ON 20-FEB-2024, CARESTREAM HEALTH INC. (CSH) WAS INFORMED OF AN UNINTENDED MOVEMENT WHILE USING THE DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM.
Patient problems: Insufficient Information
MAUDE report 18909658 ↗MalfunctionDec 22, 2023Thermal Decomposition of Device; Smoking; Thermal Decomposition of Device; Smoking
ON 14-NOV-2023, CARESTREAM HEALTH INC. WAS INFORMED OF A THERMAL INCIDENT RELATED TO THE DRX-REVOLUTION SYSTEM. NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18383235 ↗InjuryDec 12, 2023Unintended Movement; Unintended Movement
ON 18-NOV-2023, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-REVOLUTION MOBILE X-RAY SYSTEM. THE TECHNOLOGIST WAS BEHIND THE PORTABLE IN THE HALLWAY OUTSIDE THE PATIENT'S ROOM, SHE TRIED TO DRIVE FORWARD USING BOTH HANDS ON THE DRIVE HANDLE; HOWEVER, THE UNIT DROVE BACKWARDS PINNING HER BETWEEN THE WALL AND THE PORTABLE.
Patient problems: Hematoma
MAUDE report 18310300 ↗MalfunctionOct 12, 2023Smoking; Smoking
ON 27-SEP-2023, CARESTREAM HEALTH INC. WAS INFORMED THAT A CUSTOMER SITE REPORTED A THERMAL INCIDENT RELATED TO THE DRX REVOLUTION SYSTEM. NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17928156 ↗InjuryOct 12, 2023Unintended Movement; Unintended Movement
ON (B)(6) 2023, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM. THE TECHNOLOGIST WAS ON ROUTE TO A PATIENT'S ROOM AND PARKED THE UNIT. HOWEVER, AFTER LETTING GO OF THE UNIT, IT DROVE BACKWARDS INTO THE WALL. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17919720 ↗InjuryMay 25, 2023Unintended Movement; Unintended Movement
ON (B)(6) 2023, CARESTREAM HEALTH INC. WAS INFORMED ABOUT INCIDENT WHILE DRIVING THE DRX REVOLUTION SYSTEM. THE TECHNOLOGIST WAS ON ROUTE TO DO AN EXAM WHEN SHE REACHED TO HOLD THE AUTOMATIC DOOR OPEN WITH ONE HAND AND BACKED UP THE MOBILE WITH THE OTHER HAND. AS THE TECHNOLOGIST WAS REVERSING THE MOBILE, IT QUICKLY ACCELERATED AND PINNED HER AGAINST THE WALL. AS A RESULT, THE TECH EXPERIENCED PAIN IN HER RIGHT HIP AND SHE WAS LIMPING. SHE HAD ICE ON HER HIP AND WAS DIRECTED TO GO VISIT A DOCTOR FOR A FOLLOW UP VISIT. SHE WAS SENT HOME FOR THE DAY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Pain
MAUDE report 17008043 ↗MalfunctionApr 26, 2023Device Displays Incorrect Message
TECH WENT TO TAKE X-RAY ON PATIENT. WHEN IMAGES DISPLAYED ON THE SCREEN, THEY WERE FROM ANOTHER PATIENT FROM ANOTHER FACILITY. IT WAS CAUGHT AND THE CORRECT IMAGES WERE DISPLAYED ON THE CORRECT PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16814600 ↗MalfunctionApr 20, 2023Smoking; Smoking
ON 21-MAR-2023, CARESTREAM HEALTH INC. WAS INFORMED BY DEALER FE THAT A CUSTOMER SITE REPORTED A THERMAL INCIDENT RELATED TO THE DRX REVOLUTION SYSTEM. NO INJURIES REPORTED. THE INVESTIGATION IS ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777101 ↗InjuryNov 1, 2022Unintended Movement; Unintended Movement
ON (B)(6) 2022, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-REVOLUTION MOBILE X-RAY SYSTEM WHICH OCCURRED AT (B)(6), BRAZIL ON (B)(6) 2022. PER CARESTREAM HEALTH SERVICE PERSONNEL INVESTIGATION WHICH CONFIRMED THE FOLLOWING: THE SYSTEM IN "AS FOUND" CONDITION: FOUND NO ABNORMALITY IN THE DRIVING CART. AT THE TIME OF THE INCIDENT, THE SYSTEM WAS BEING DRIVEN BY A SITE TECH. THE TECHNOLOGIST WAS REVERSING THE SYSTEM OUT OF AN ELEVATOR WHEN THE DRX-REVOLUTION PASSED OVER THE OPERATOR'S TOE. THE INCIDENT RESULTED IN A TOE INJURY WHERE THE TECH'S TOE WAS FRACTURED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Bone Fracture(s)
MAUDE report 15708210 ↗InjuryJun 22, 2022Sparking; Sparking
ON (B)(6) 2022, CARESTREAM HEALTH (CSH) WAS INFORMED, OF AN INCIDENT WHICH OCCURRED AT KAISER MT. VIEW. THE SITE ALLEGED THAT WHILE PLUGGING IN THE DRX-REVOLUTION SYSTEM, A TECH OBSERVED A SPARK AND THEN FELT ELECTRICITY THROUGH THEIR HAND. THE TECH VISITED THE EMERGENCY ROOM DUE TO EXPERIENCING HEART PALPITATIONS AFTER THE INCIDENT. THERE HAVE BEEN NO ADDITIONAL DETAILS REGARDING THE TECH'S STATUS OR CONDITION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14779447 ↗InjuryMay 26, 2022Unintended Movement; Unintended Movement
ON 03-MAY-2022, CARESTREAM HEALTH (CSH) WAS INFORMED, VIA EMAIL, OF AN INCIDENT RELATED TO THE DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM WHICH OCCURRED AT (B)(6) ON (B)(6) 2021 (AS REPORTED BY SITE - ACTUAL DAY UNKNOWN). PER CARESTREAM HEALTH SERVICE PERSONNEL INVESTIGATION WHICH CONFIRMED THE FOLLOWING: THE SYSTEM IN "AS FOUND" CONDITION: NORMAL WORKING CONDITIONS WITH NO ISSUES. AT THE TIME OF THE INCIDENT, (B)(6) 2021 - EXACT DATE IS UNKNOWN AS THE INCIDENT WAS NOT REPORTED TO CSH AT THAT TIME, THE SYSTEM WAS BEING DRIVEN BY A SITE TECH. PER THE REPORT, THE TECHNOLOGIST ALLEGED THEY WAS REVERSING THE MOBILE OUT OF AN INPATIENT ROOM AT (B)(6). AS THE TECHNOLOGIST WAS TURNING THE MOBILE, IT SWUNG QUICKLY AND TRAPPED HER LEG BETWEEN THE WALL AND THE PORTABLE. AS THE MOBILE HAD COLLIDED WITH SOMETHING, IT WAS DIFFICULT TO MOVE IT AND HER LEG WAS CRUSHED FOR A FEW SECONDS. SHE HAD BRUISING AT THE TIME AND A FEW MONTHS LATER, SHE WAS EXPERIENCING INTERMITTENT PAIN WHEN WALKING/STANDING BEHIND HER KNEE IN THE PLACE IT WAS PINNED. SHE WENT TO PHYSIO, AND THEY STATED IT WAS AN INJURY TO HER HAMSTRING. SHE RECEIVED TREATMENT BY PHYSIO AND THE PAIN SUBSIDED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Pain
MAUDE report 14507768 ↗
Other Carestream Health, Inc. products
All Carestream Health, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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