DRX-Revolution Mobile X-ray System (REF 1019397)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 60889971019394), received between Oct 27, 2020 and Nov 27, 2025 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 reports).

2 FDA recall records name this device's identifier, 2 still open.

7 other recalls cover devices cleared under the same FDA submission (K120062); 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.

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 ↗

2. Oct 2, 2023Open, Classified

   Unexpected failure of electrical components within the CPI generator.

   Z-0437-2024 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 14, 2021Thermal Decomposition of Device; Smoking

  ON 18-SEP-2021, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-REVOLUTION MOBILE X-RAY SYSTEM WHICH OCCURRED AT (B)(6) HOSPITAL - KOREA. THE DEALER ALLEGED A THERMAL EVENT OCCURRED WITH THE DRX REVOLUTION SYSTEM. THREE INDIVIDUALS WITHIN THE VICINITY OF THE SYSTEM WERE TREATED FOR SMOKE INHALATION AND RELEASED THE SAME DAY WITH NO ADDITIONAL TREATMENT REQUIRED.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631162 ↗
• InjuryAug 11, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2021, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-REVOLUTION MOBILE X-RAY SYSTEM. INITIALLY THE SITE BIOMED, (B)(6), CALLED IN WITH A REQUEST TO SLOW DOWN THE BACKUP SPEED OF THE DRX REVOLUTION SYSTEM. WHEN INFORMED THAT THE SPEED CANNOT BE CHANGED, (B)(6) CALLED CARESTREAM HEALTH (CSH) AND REPORTED AN INJURY. SPECIFICALLY, (B)(6) (LAST NAME NOT PROVIDED DUE TO PRIVACY) - A TRAINED SITE TECH, BACKED THE MACHINE OVER HER FOOT/ANKLE WHILE DRIVING THE SYSTEM WITH ONE HAND. SHE IS CURRENTLY OUT OF WORK DUE TO INJURY. THE BIOMED STATED THAT THERE WERE NO MALFUNCTIONS WITH THE DRX REVOLUTION AT THE TIME OF THE INCIDENT. CSH FIELD SERVICE HAS ATTEMPTED TO CONFIRM AND OBTAIN DETAILS RELATED TO THE INCIDENT, HOWEVER, THE SITE WILL NOT PROVIDE ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 12310843 ↗
• MalfunctionMay 4, 2021Patient Data Problem

  PROBLEMS WITH THE DRX-REVOLUTION MOBILE X-RAY SYSTEM STARTED WITH PATIENT IMAGES NOT SAVING IN CORRECT PATIENT EXAM AFTER EXPOSURE. X-RAY TECH WAS ABLE TO FIND CORRECT PATIENT IMAGE IN INCORRECT PATIENTS FOLDER. CARESTREAM HEALTH WAS NOTIFIED BY BIOMEDICAL TEAM AND WAS ONSITE TO DIAGNOSE THE ISSUE. LOG FILES WERE DOWNLOADED AND SENT TO CARESTREAM NATIONAL SUPPORT TEAM TO DETERMINE POSSIBLE CAUSE OF ISSUE. SETTING CHANGES, RECOMMENDED BY NATIONAL SUPPORT, WERE MADE ON THE DEVICES. ERRORS CONTINUED. CARESTREAM WAS PRESENT DAILY WITH ON-GOING TROUBLE SHOOTING. ERROR ESCALATED UP THROUGH EXECUTIVE TEAM. TWO WEEKS ON GOING WITH NO RESOLUTION. SAME ERROR ON PORTABLE AT SISTER HOSPITAL, ONLY COMMONALITY IS THAT BOTH PORTABLES ARE FIRST GENERATION REVOLUTION WITH SAME SOFTWARE VERSIONS.

  Patient problems: Insufficient Information

  MAUDE report 11768814 ↗
• InjuryApr 13, 2021Unintended Movement; Unintended Movement

  THE SITE BIOMED REPORTED THAT A STUDENT TECH WAS MANEUVERING THE DRX REVOLUTION SYSTEM BETWEEN TWO BEDS IN A PATIENT'S ROOM. THE STUDENT BEGAN TO MOVE THE SYSTEM OUT FROM BETWEEN THE TWO BEDS AND STARTED TO TURN THE UNIT TOWARDS THE ENTRANCE/EXIT DOOR TO THE ROOM WHEN THE SYSTEM MOVED BACKWARDS TOWARD HER. ACCORDING TO THE REPORT, THE DRX REVOLUTION CONTACTED THE STUDENT TECH'S GROIN AREA. THERE WAS NO DISCOLORATION OF THE AREA, BUT THE STUDENT EXPERIENCES, AND STILL EXPERIENCES PAIN WHEN SHE TOUCHES THE AREA. THE TECH NOTED A LUMP IN THE AREA; HOWEVER, THERE WERE NO BROKEN BONES OR FRACTURES. THE TECH WAS EXAMINED IN THE EMERGENCY DEPARTMENT AFTER THE INCIDENT BUT HAS NOT NEEDED FURTHER CARE SINCE THIS TIME. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Pain

  MAUDE report 11654288 ↗
• InjuryDec 17, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  WHILE OPERATING THE DRX REVOLUTION SYSTEM, THE SITE LEAD TECH RAN OVER HER RIGHT FOOT, BIG TOE REQUIRING MEDICAL ATTENTION. THE RESULTING INJURY WAS A HAIR FRACTURE TO THE RIGHT FOOT, BIG TOE. THE TOE AND NAIL WERE DARK AND BRUISED. THE TECH WAS PLACED ON CHAIR DUTY TO THE INJURY.

  Patient problems: Bone Fracture(s)

  MAUDE report 11033226 ↗
• InjuryOct 27, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE SITE ALLEGED THAT WHILST DRIVING THE DRX REVOLUTION OUT OF AN ELEVATOR ON (B)(6) 2020, THE SYSTEM JERKED BACKWARDS ONTO THE TECH'S FOOT RESULTING IN A BROKEN TOE INJURY. THE TECH WAS OUT OF WORK DUE TO INJURY.

  Patient problems: Bone Fracture(s)

  MAUDE report 10744914 ↗
• InjuryOct 27, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE SITE ALLEGED THAT WHILST DRIVING THE DRX REVOLUTION OUT OF AN ELEVATOR ON (B)(6) 2020, THE SYSTEM JERKED BACKWARDS ONTO THE TECH'S FOOT RESULTING IN A BROKEN TOE INJURY. THE TECH WAS OUT OF WORK DUE TO INJURY.

  Patient problems: Bone Fracture(s)

  MAUDE report 10744849 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120062. One submission often covers many models, so check the product and lot details in each record.

• Z-2651-2017 · May 25, 2017 · Terminated
  DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolu
• Z-1138-2017 · Jan 12, 2017 · Terminated
  Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Stree
• Z-0800-2015 · Nov 25, 2014 · Terminated
  DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revoluti
• Z-0179-2014 · Aug 29, 2013 · Terminated
  DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinat
• Z-0090-2014 · Jul 26, 2013 · Terminated
  DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The
• Z-0132-2014 · Jun 19, 2013 · Terminated
  DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x
• Z-0126-2014 · Jun 6, 2013 · Terminated
  Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.