FDA Device recall Z-0551-2024
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS
- FDA Device
- Class II
- ongoing
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class II recall of Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS by Change Healthcare Canada, citing under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0551-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-01 |
| Published | 2023-12-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Change Healthcare Canada |
| Distribution | US |
Product
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Reason
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
Identifiers
| code_info | Version 1.4, UDI (01)17540262160093(10)010400 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Change Healthcare Canada
- Change Healthcare Radiology Solutions software version 14.2.2
FDA Device · Class II · 2025-10-08 · Change Healthcare Canada - Change Healthcare Cardiology Hemodynamics Software
FDA Device · Class II · 2025-07-09 · Change Healthcare Canada - Change Healthcare Cardiology Hemo Software
FDA Device · Class II · 2025-07-09 · Change Healthcare Canada - Change Healthcare Cardiology Hemo
FDA Device · Class II · 2024-10-23 · Change Healthcare Canada - McKesson Cardiology Hemo
FDA Device · Class II · 2024-10-23 · Change Healthcare Canada
All Change Healthcare Canada recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0551-2024%22
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