DRX REVOLUTION MOBILE X-RAY SYSTEM

Report

Report Number: 1317307-2025-00004
Event Type: Malfunction
Date Received: November 27, 2025
Date of Event: October 28, 2025
Report Date: March 19, 2026
Manufacturer: CARESTREAM HEALTH INC.
Product Code: IZL
UDI-DI: 60889971019394
PMA / PMN Number: K191025
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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.

Additional Manufacturer Narrative · 0

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.

Additional Manufacturer Narrative · 0

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.

Additional Manufacturer Narrative · 0

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 · 0

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.