FDA Adverse Event Injury Summary report: N

EOS IMAGING

MDR report key: 24778475 · Received April 3, 2026

Report

Report Number: 3006165260-2026-00003
Event Type: Injury
Date Received: April 3, 2026
Date of Event: January 29, 2026
Report Date: April 3, 2026
Manufacturer: EOS IMAGING
Product Code: KPR
UDI-DI: 03663999000399
PMA / PMN Number: K233920
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE INVESTIGATION IS CLOSED BASED ON THE CURRENT FINDINGS, AND IT WILL BE REOPENED IF NEW INFORMATION COMES TO OUR ATTENTION. THE MOST PROBABLE ROOT CAUSE REMAINS INCORRECT PATIENT POSITIONING OR INADEQUATE COLLIMATION, WHICH INTERFERED WITH THE DETECTION OF THE SALIENT POINTS USED BY THE AUTOMATIC EXPOSURE CONTROL, AS OBSERVED IN PREVIOUS CASES. THE ABSENCE OF DOSE DATA OR IMAGES PREVENTS ANY CONFIRMATION OR PRECISE QUANTIFICATION. A TRAINING ACTION WAS IMPLEMENTED IMMEDIATELY, AND INTERNAL IMPROVEMENT OPPORTUNITIES REGARDING THE DISPLAY OF DOSE LEVELS WITHIN PROTOCOLS AND THE RECALCULATION OF THE MA PROFILE AFTER COLLIMATION HAVE BEEN IDENTIFIED.

Description of Event or Problem · 0

THE EVENT (B)(6) WAS REPORTED ON MARCH 5, 2026, BY (B)(6), MARKETING DIRECTOR, AFTER THE (B)(6) NOTIFIED ANOTHER CASE OF ABNORMALLY HIGH DOSE DURING AN ARM ACQUISITION PERFORMED WITH THE EOSEDGE SYSTEM. THE CIRCUMSTANCES WERE SIMILAR TO THOSE OF THE TWO PREVIOUS CASES, AND NO CLINICAL CONSEQUENCES WERE REPORTED FOR THE PATIENTS INVOLVED. A CUSTOMER COMPLAINT WAS OPENED IN ORDER TO IDENTIFY THE ORIGIN OF THESE UNUSUAL DOSE VALUES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
838829	EOS IMAGING	EOSEDGE	KPR	EOS IMAGING	3.1.0		03663999000399

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other