MAUDE Adverse Event Report: CARESTREAM HEALTH INC. CARESTREAM DRX EVOLUTION PLUS SYSTEM

Catalog Number	8624264
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	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
Carestream health inc.(csh) has investigated this issue and it was determined that this was not a device malfunction; and no design or manufacturing issues were identified.The detachment resulted from improper service installation, as the mounting wedge blocks had not been fully secured during servicing performed 1-2 days earlier.The collimator was resecured, and the service team was reminded of the correct installation procedure.No patient or staff injuries occurred.Although the detachment resulted from a service installation error, it occurred during clinical use, meaning that recurrence under similar conditions could likely cause serious injury.Therefore, the event is being reported to the fda.The risk has been mitigated as far as possible.No further actions are required, and carestream health has closed the investigation.

• Brand Name: CARESTREAM DRX EVOLUTION PLUS SYSTEM
• Common Device Name: CARESTREAM DRX EVOLUTION PLUS 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 14608
• Manufacturer Contact: alejandra benitez ; 150 verona street; rochester, NY 14608 ; 5856278533
• MDR Report Key: 24218943
• Report Number: 1317307-2026-00001
• Device Sequence Number: 8326008
• Product Code: KPR
• UDI-Device Identifier: 60889978624263
• UDI-Public: 0160889978624263
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

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: 8624264
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2022
• 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