Change Healthcare Cardiology 15.0.1Recalls & reported problems
Change Healthcare Canada Company · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 17540262090116), received between Jul 2, 2024 and Jul 2, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Markings/Labelling Problem1
- Labelling, Instructions for Use or Training Problem1
- Missing Information1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2024Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Missing Information; Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Missing Information
THE CUSTOMER WAS USING CHANGE HEALTHCARE CARDIOLOGY 15.0.1 AND REPORTED THAT STUDIES WERE BEING FILTERED INCORRECTLY BY THE DATE/TIME ON THE WORKLIST. THE CUSTOMER NOTICED THAT TWO PATIENTS HAD STUDIES WITH THIS ISSUE. THERE WERE NO REPORTED ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.
Patient problems: Insufficient Information
MAUDE report 19657694 ↗
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- IntelliSpace Cardiovascular 8Philips Medical Systems Nederland B.V. · System, Image Processing, Radiological2 recalls132 reports
- CA1000 2.0 SP 14Ge Healthcare · System, image processing, radiological4 recalls0 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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