Vue PACS (REF 1201284)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 60889971041692), received between Mar 7, 2020 and Mar 7, 2020 — classified as 1 death.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• DeathMar 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE HOSPITAL SITE REPORTED THAT THE CARESTREAM VUE PACS ALLEGEDLY CONTRIBUTED TO A PATIENT DEATH DUE TO THE SYSTEM BEING DOWN AND PATIENT IMAGES NOT ACCESSIBLE.

  Patient problems: Death

  MAUDE report 9803595 ↗

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-0245-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; UPG MX-O SVR 25K 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-0246-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; UPG MX-O SVR 75K 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-0239-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area
• Z-0257-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; UPG MX-RAD 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
• 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-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-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-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-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-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-0232-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PA
• Z-0212-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area
• Z-0221-2014 · Sep 16, 2013 · Terminated
  Carestream Vue PACS; Virtual Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide are

…and 35 more.