MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VUE PACS; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number	VUE PACS
Medical Device Problem Code	Application Program Version or Upgrade Problem (2881)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on vue motion indicating that after upgrading the system from 12.2.8.570 to 12.2.8.600, the customer experienced bookmarks returning incorrect and inaccurate results.
Additional Manufacturer Narrative
On (b)(6) 2025, the customer reported an issue related to the device vue motion software version -12.2.8.600 which occurred outside united states and its jurisdiction.The vue motion s/w version 12.2.8.600 and similar devices were never installed in usa.The deployment was performed only in three sites outside usa and its jurisdictions.Philips received a complaint on vue motion indicating that after upgrading the system from 12.2.8.570 to 12.2.8.600 the customer experienced measurement issues in the pacs and saved as bookmark which is resulting in incorrect and inaccurate results.Philips investigation revealed that 2d bookmarks created prior to version 12.2.8.600 and accessed through the system after upgrading to version 12.2.8.600 do not preserve the original measurement specified by the user upon subsequent access.The measurement graphic location (on the same image), size and values, as well as its representative bookmark might be changed.Upon closing the study, the updated bookmark graphic data is saved to the database, potentially affecting subsequent analyses.Hence this is a result in a design error in the system.As a workaround the bookmark functionality was disabled.The fix for the identified bug is available in version 12.2.8.610 and it will be released to the impacted customer with field safety corrective action (fsca).This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.Based on risk evaluation, if this event were to recur it could cause serious injury or death.Therefore, based on the available information this complaint is considered a reportable event.

• Brand Name: VUE PACS
• Common Device Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: edita reznik-shmueli ; veenpluis 6; best 5684 -PC ; NL 5684 PC
• MDR Report Key: 23879027
• Report Number: 3003768277-2025-015869
• Device Sequence Number: 4771274
• Product Code: LLZ
• UDI-Device Identifier: 00884838100367
• UDI-Public: (01)00884838100367(11)250820(10)12.2.8.600
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K151774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VUE PACS
• Device Catalogue Number: 1017979
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 12/23/2025
• 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