Class II — CHANGE HEALTHCARE CANADA COMPANY
| Recalling firm | Change Healthcare Canada Company |
|---|---|
| Registered facility | CHANGE HEALTHCARE CANADA COMPANY (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study. |
| Product | Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS. |
| Quantity | 454 |
| Distribution | US Nationwide distribution. There was no military/government distribution. |
| Initiated | 2023-11-01 |
| Classified | 2023-12-14 |
| Recall number | Z-0551-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CHANGE HEALTHCARE CANADA COMPANY (Z-0551-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93451/
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