Vue PACS Vue PACS - 12Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884838100336), received between Apr 11, 2024 and Apr 11, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

50 other recalls cover devices cleared under the same FDA submission (K110919); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 5, 2026Class IIOpen, Classified

   Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.

   Z-1692-2026 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT HAS BEEN REPORTED TO PHILIPS BY (B)(4) ((B)(6)) THAT A CUSTOMER REPORTED THAT DURING SURGICAL OPERATION VUE PACS WAS ON STANDBY AND SHUTDOWN, THIS PREVENTED THE SURGEON TO VIEW THE NECESSARY X-RAY IMAGES FOR SURGERY. THE SYSTEM WAS IN CLINICAL USE WHEN THIS OCCURRED. THERE WAS NO REPORT OF HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19091057 ↗
• MalfunctionApr 11, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT HAS BEEN REPORTED TO PHILIPS BY SWISSMEDIC ((B)(4)) THAT A CUSTOMER REPORTED THAT DURING SURGICAL OPERATION VUE PACS WAS ON STANDBY AND SHUTDOWN, THIS PREVENTED THE SURGEON TO VIEW THE NECESSARY X-RAY IMAGES FOR SURGERY. THE SYSTEM WAS IN CLINICAL USE WHEN THIS OCCURRED. THERE WAS NO REPORT OF HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19089840 ↗
• MalfunctionApr 11, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT HAS BEEN REPORTED TO PHILIPS BY SWISSMEDIC (GHOL-SIG-2024-042) THAT A CUSTOMER REPORTED THAT DURING SURGICAL OPERATION VUE PACS WAS ON STANDBY AND SHUTDOWN, THIS PREVENTED THE SURGEON TO VIEW THE NECESSARY X-RAY IMAGES FOR SURGERY. THE SYSTEM WAS IN CLINICAL USE WHEN THIS OCCURRED. THERE WAS NO REPORT OF HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19089524 ↗
• MalfunctionApr 11, 2024Patient Data Problem; Patient Data Problem

  IT HAS BEEN REPORTED TO PHILIPS BY SWISSMEDIC (GHOL-SIG-2024-055) THAT A CUSTOMER REPORTED THAT VUE PACS DISPLAYS PATIENT X, BUT WHEN DOUBLE-CLICKED PATIENT Y APPEARS IN THE WORKLIST. THE SYSTEM WAS IN CLINICAL USE WHEN THIS OCCURRED. THERE WAS NO REPORT OF HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088522 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110919. One submission often covers many models, so check the product and lot details in each record.

• Z-0497-2025 · Oct 10, 2024 · Open, Classified
  Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Pictu
• Z-0235-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area
• Z-0259-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area
• Z-0219-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; Virtual Enterprise SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area P
• Z-0216-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area
• Z-0256-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area
• Z-0233-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area P
• Z-0231-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS
• Z-0215-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide
• Z-0248-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area
• Z-0222-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PA
• Z-0220-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide
• Z-0237-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 25K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area
• Z-0253-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area
• Z-0240-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area P

…and 35 more.