McKesson Radiology 12.3Recalls & reported problems
Change Healthcare Canada Company · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 17540262020014), received between Jan 5, 2019 and Jan 5, 2019 — classified as 1 death.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJan 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTING FACILITY CONTACTED CHANGE HEALTHCARE'S CUSTOMER SUPPORT TEAM TO DETERMINE WHETHER AN IMAGING STUDY PERFORMED FOR AN EMERGENCY PATIENT HAD BEEN IMPORTED INTO MCKESSON RADIOLOGY PACS FROM THE MODALITY, AS THE REPORTING FACILITY HAD BEEN UNABLE TO LOCATE THE STUDY IN THE SYSTEM. THE REPORTING FACILITY INDICATED THE PATIENT HAD SUBSEQUENTLY EXPIRED.
Patient problems: Death
MAUDE report 8220473 ↗
Other System, Image Processing, Radiological devices
- Interventional Workspot Interventional Workspot - 1Philips Medical Systems Nederland B.V. · System, Image Processing, Radiological13 recalls24 reports
- Synapse Radiology PACS Synapse Radiology PACS Software LicenseFujifilm Healthcare Americas Corporation · System, image processing, radiological9 recalls38 reports
- CENTRICITY UNIVERSAL VIEWER ZFP CLIENT 6.0Ge Healthcare · System, image processing, radiological8 recalls0 reports
- CENTRICITY UNIVERSAL VIEWER 6.0Ge Healthcare · System, image processing, radiological8 recalls0 reports
- CENTRICITY UNIVERSAL VIEWER 7.0Ge Healthcare · System, image processing, radiological6 recalls0 reports
- 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
- VMA 2Ortho Kinematics, Inc. · System, Image Processing, Radiological4 recalls0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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