Change Healthcare Radiology Solutions 14.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 17540262030020), received between Sep 4, 2020 and Sep 4, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Application Program Problem” (1 report).

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

2 other recalls cover devices cleared under the same FDA submission (K140909); 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. Oct 12, 2023Class IIOpen, Classified

   Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications.

   Z-0237-2024 · Root cause: Software design · Recall details · FDA record ↗

2. Aug 25, 2020Class IITerminated

   Software defect which may potentially result in one or more images missing in a study

   Z-0072-2021 · Root cause: Process design · Recall details · FDA record ↗

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.

• MalfunctionSep 4, 2020Computer Software Problem; Application Program Problem; Computer Software Problem; Application Program Problem

  FOLLOWING AN UPGRADE TO CHRS 14.0 A CUSTOMER SITE, THE CUSTOMER REPORTED ISSUES ON (B)(6) 2020 WHERE SOME NEWLY IMPORTED ULTRASOUND IMAGES WEREN'T IN ORDER AND SOME OF THEM WERE CUT OFF AND BLACK. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 10495255 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140909. One submission often covers many models, so check the product and lot details in each record.

• Z-0030-2026 · Aug 13, 2025 · Open, Classified
  Change Healthcare Radiology Solutions software version 14.2.2
• Z-1396-2017 · Dec 2, 2016 · Terminated
  McKesson Radiology 12.2 - Picture Archive Communication System (PACS)