FDA Adverse Event Malfunction Summary report: N

VUE PACS

MDR report key: 23621400 · Received November 21, 2025

Report

Report Number
MW5179300
Event Type
Malfunction
Date Received
November 21, 2025
Report Date
November 18, 2025
Manufacturer
PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.
Product Code
LLZ
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
PHYSICIAN
Health Professional
*

Narratives

Description of Event or Problem · 0

MY NAME IS DR. (B)(6), DO. I AM A RADIOLOGIST AND WORK FOR (B)(6). WE USE VUE PACS SINCE (B)(6) OF 2025. FEATURE SUCH AS MISLEADING REFERENCE LINE MIGHT LEAD TO REPORTING OF PATHOLOGICAL FINDINGS ON A WRONG ANATOMICAL SITE WHICH COULD BE HARMFUL FOR PATIENTS. I TRIED TO EXPLAIN THIS TO IT FROM PHILIPS SINCE (B)(6) 2025, HOWEVER WITHOUT SUCCESS. OTHERWISE VUE PACS IS SLOW, INCONVENIENT AND FULL OF UNNECESSARY FEATURES. I WOULD NOT RECOMMEND USING IT. BELOW IS PRODUCT NAME THAT I FOUND ON YOUR WEB SITE. THANKS. (B)(6), DO PROPRIETARY NAME: VUE MOTION; VUE PACS; VUE PACS (DIAGNOSTIC) CLASSIFICATION NAME: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL PRODUCT CODE: LLZ DEVICE CLASS: 2, REGULATION NUMBER: (B)(4), MEDICAL SPECIALTY: RADIOLOGY, REGISTERED ESTABLISHMENT NAME: PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD. REGISTERED ESTABLISHMENT NUMBER: (B)(4), PREMARKET SUBMISSION NUMBER: K110919, OWNER/OPERATOR: PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV, OWNER/OPERATOR NUMBER: (B)(4), ESTABLISHMENT OPERATIONS: MANUFACTURER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2578034 VUE PACS SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other