DRX-Revolution Mobile X-ray System (REF 8618894)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 60889978618897), received between Oct 21, 2020 and May 23, 2024 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (8 reports).

1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryMay 25, 2022Unintended Movement; Unintended Movement

  ON (B)(6) 2022, CARESTREAM HEALTH (CSH) WAS INFORMED, VIA EMAIL, OF AN INCIDENT RELATED TO THE DRX-REVOLUTION PLUS MOBILE XRAY SYSTEM WHICH OCCURRED AT DR (B)(6) ON (B)(6) 2022. 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, THE SYSTEM WAS BEING DRIVEN BY A SITE TECH. PER THE REPORT, THE TECH/OPERATOR WAS HOLDING A DOOR OPEN WITH ONE HAND AND ATTEMPTING TO DRIVE THE DRX REVOLUTION PLUS SYSTEM WITH THE OTHER HAND WHEN BACKING INTO THE INTENSIVE CARE UNIT AND DROVE THE SYSTEM OVER HER FOOT. THE TECH WAS ABLE TO DRIVE THE SYSTEM FORWARD OFF OF HER FOOT. THE INCIDENT RESULTED IN A TOE INJURY WHERE THE TECH LOST THE TOE NAIL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14501337 ↗
• MalfunctionMay 6, 2022Insufficient Device Problem Information; No Visual Prompts/Feedback; Insufficient Device Problem Information; No Visual Prompts/Feedback

  ON 08-APR-22, CARESTREAM HEALTH (CSH) WAS NOTIFIED OF AN INCIDENT RELATED TO THE DRX REVOLUTION SYSTEM: THE INCORRECT PATIENT WAS COMPLETED, BUT 2D BARCODE READER/SOFTWARE DID VERIFY THE PATIENT. THERE HAS BEEN NO INJURY, MISDIAGNOSIS OR ANY PATIENT SAFETY IMPACT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14313031 ↗
• InjuryMay 6, 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 SOUTH EAST HEALTH- US. THE SITE REPORTED THAT A RAD TECH WAS BACKING THE REVOLUTION PLUS PORTABLE OUT OF THE PATIENT ROOM AND THE UNIT SUDDENLY BACKED UP PINNING HER ARM AGAINST THE WALL. HER ARM WAS SORE AND BRUISED. THE TECH WENT TO THE EMERGENCY ROOM FOR AN X-RAY OF HER ELBOW WHICH SHOWED NO BROKEN BONES. THE INJURY CONSISTED OF A SORE AND BRUISED ARM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Bruise/Contusion

  MAUDE report 14312551 ↗
• InjuryApr 1, 2022Unintended Movement; Unintended Movement

  ON 16-MAR-2022, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM WHICH OCCURRED AT (B)(6) HOSPITAL - (B)(6). THE SITE RADIOGRAPHER ALLEGED THAT ON (B)(6) 2022, WHILE TRANSPORTING THE DRX REVOLUTION PLUS SYSTEM THROUGH IN AN ELEVATOR, THE RADIOGRAPHER WAS HIT ON THE HEAD BY THE TUBE HEAD OF THE SYSTEM. THIS RESULTED IN A HEAD INJURY WHICH REQUIRED HOSPITALIZATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Head Injury

  MAUDE report 13973540 ↗
• InjurySep 1, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE CUSTOMER SITE ALLEGED THAT THE TECH/OPERATOR WAS TRYING TO HOLD A DOOR OPEN WITH ONE HAND AND DRIVE THE CART WITH THE OTHER HAND (1 HAND). AS A RESULT, THE TECH DROVE THE DRX REVOLUTION OVER HER FOOT RESULTING IN BROKEN TOE INJURY.

  Patient problems: Bone Fracture(s)

  MAUDE report 12411699 ↗
• InjuryOct 21, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE CUSTOMER SITE ALLEGED THAT WHILE IN A HURRY, THE OPERATOR WAS TRYING TO HOLD A DOOR OPEN WITH ONE HAND AND DRIVE THE CART WITH THE OTHER HAND (1 HAND), ALL WHILST STANDING BESIDE THE MACHINE. AS A RESULT, THE TECH DROVE THE DRX REVOLUTION OVER HER TOES, RESULTING IN BROKEN TOES.

  Patient problems: Bone Fracture(s)

  MAUDE report 10709498 ↗