Vue PACS (REF 1149418)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 60889971047809), received between Jul 30, 2026 and Jul 30, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Computer Operating System Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Computer Operating System Problem

  The manufacturer received a complaint indicating that the user was unable to access site examinations. Consequently, the user was unable to interpret a scanner for a patient. The patient deteriorated and critically damaged his health status. The customer called an interpretation urgently with a 3rd party company.

  Patient problems: Insufficient Information

  MAUDE report 50083162 ↗

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-0250-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area
• 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-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-0228-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; UNLIMITED READING LIC ADD 10K 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-0249-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area
• Z-0227-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area P
• 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-0224-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area
• Z-0243-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PA
• 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
• Z-0230-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area
• Z-0211-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area
• 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

…and 35 more.