Change Healthcare Radiology SolutionsRecalls & reported problems across all models
Change Healthcare Canada Company · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Change Healthcare Radiology Solutions model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 3
We found 2 models of Change Healthcare Radiology Solutions by Change Healthcare Canada Company in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, 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).
3 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Change Healthcare Radiology Solutions recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 13, 2025Class IIOpen, Classified
Due to software issue, radiology reports may not be fully displayed when viewing.
Z-0030-2026 · Root cause: Software Design Change · Recall details · FDA record ↗
- 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 ↗
- 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 Change Healthcare Radiology Solutions problems
Device problems
- Application Program Problem1
- Computer Software Problem1
Patient problems
- Patient Problem/Medical Problem1
Change Healthcare Radiology Solutions models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Change Healthcare Radiology Solutions 14.0System, Image Processing, Radiological2 recalls1 report
- Change Healthcare Radiology Solutions 14.2.2System, Image Processing, Radiological1 recall0 reports
Recent Change Healthcare Radiology Solutions adverse event reports
The 1 most recent reports across all models, 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 ↗
Other Change Healthcare Canada Company products
All Change Healthcare Canada Company devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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