| 2025-08-13 |
Class II
|
Ongoing |
Z-0030-2026 |
Change Healthcare Radiology Solutions software version 14.2.2 |
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Due to software issue, radiology reports may not be fully displayed when viewing. |
| 2025-05-22 |
Class II
|
Ongoing |
Z-2072-2025 |
Change Healthcare Cardiology Hemodynamics Software |
— |
Due to complaints, software update may cause software to unexpectedly shutdown. |
| 2025-05-22 |
Class II
|
Ongoing |
Z-2071-2025 |
Change Healthcare Cardiology Hemo Software |
— |
Due to complaints, software update may cause software to unexpectedly shutdown. |
| 2024-08-21 |
Class II
|
Ongoing |
Z-0128-2025 |
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0. |
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A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potential… |
| 2024-08-21 |
Class II
|
Ongoing |
Z-0127-2025 |
Horizon Cardiology Hemo. Version 12.2. |
— |
A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potential… |
| 2024-08-21 |
Class II
|
Ongoing |
Z-0126-2025 |
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1. |
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A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potential… |
| 2023-11-01 |
Class II
|
Ongoing |
Z-0551-2024 |
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS. |
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Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's… |
| 2023-10-12 |
Class II
|
Ongoing |
Z-0237-2024 |
Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management … |
— |
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 applicatio… |
| 2021-04-19 |
Class II
|
Ongoing |
Z-1773-2021 |
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D d… |
— |
A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV. |
| 2021-03-17 |
Class II
|
Ongoing |
Z-1508-2021 |
Change Healthcare Enterprise Viewer |
— |
Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display. |
| 2020-08-25 |
Class II
|
Terminated |
Z-0072-2021 |
Change Healthcare Radiology Solutions 14.0 |
— |
Software defect which may potentially result in one or more images missing in a study |
| 2020-02-10 |
Class II
|
Ongoing |
Z-1682-2020 |
McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management |
— |
Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format |