MAUDE Adverse Event Report: CARESTREAM HEALTH INC. DRX REVOLUTION MOBILE X-RAY SYSTEM

Catalog Number	8610180
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Csh investigation is currently in progress.Submitting an initial report as there are currently insufficient facts available to make areportability decision and at least 29 days have elapsed.Csh will submit a follow up with investigation update/findings within 30 days.
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
On november 27, 2025 an initial report was submitted as there were insufficient facts available to make a reportability decision.Submitting a follow up #1 as investigation is ongoing.Csh will submit a follow up with investigation update/findings within 30 days.
Additional Manufacturer Narrative
On november 27, 2025 an initial report was submitted as there were insufficient facts available to make a reportability decision.Submitting a follow up #2 as investigation is ongoing.Csh will submit a follow up with investigation update/findings within 30 days.
Event or Problem Description
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.
Additional Manufacturer Narrative
On november 27, 2025 an initial report was submitted as there were insufficient facts available to make a reportability decision.Investigation and testing confirmed that the failure was caused by fatigue, with no manufacturing or material defects identified.The current root cause is assessed as improper or excessive use, resulting in damage to the boom assembly.Visual inspection of the images and the returned boom assembly indicates that the equipment may have been used beyond its intended or expected use.Internal finite element analysis (fea) did not identify a design deficiency; however, carestream health has also engaged an external analyst to review and confirm the internal findings.Therefore, csh is submitting follow up #3.Csh will submit a final report with investigation update/findings within 30 days.
Event or Problem Description
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.
Additional Manufacturer Narrative
Carestream health inc.(csh) has investigated this issue.The investigation and testing confirmed that the failure was caused by fatigue, with no manufacturing or material defects identified.There were no injuries as a result of this issue and there was no patient involvement.The current root cause is assessed as improper or excessive use, resulting in damage to the boom assembly.Visual inspection of the images and the returned boom assembly indicates that the equipment may have been used beyond its intended or expected use.Internal finite element analysis (fea) did not identify a design deficiency.The damaged boom assembly was replaced.The risk has been mitigated as far as possible.There are no further actions by carestream health at this time.Should new information emerge that necessitates fda reporting, carestream will submit an updated report.
Event or Problem Description
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.There was no patient involvement.

• Brand Name: DRX REVOLUTION MOBILE X-RAY SYSTEM
• Common Device Name: DRX REVOLUTION MOBILE X-RAY SYSTEM
• Manufacturer (Section D): CARESTREAM HEALTH INC.; 150 verona street; rochester NY 14608
• Manufacturer (Section G): CARESTREAM HEALTH INC.; 1049 ridge road west; rochester NY 14615
• Manufacturer Contact: alejandra benitez ; 150 verona street; rochester, NY 14608 ; 5856278533
• MDR Report Key: 23667674
• Report Number: 1317307-2025-00004
• Device Sequence Number: 8910315
• Product Code: IZL
• UDI-Device Identifier: 60889971019394
• UDI-Public: (01)60889971019394
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8610180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 10/29/2025; 10/29/2025; 10/29/2025; 10/29/2025
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 12/26/2025; 01/23/2026; 02/20/2026; 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown