Change Healthcare Stratus Imaging PACS 1 — Class II medical device recall Z-0551-2024
Ongoing recall by CHANGE HEALTHCARE CANADA COMPANY, reported 2023-12-20, distributed nationwide. Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has
| Recall number | Z-0551-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CHANGE HEALTHCARE CANADA COMPANY, Richmond, N/A, Canada |
| Recall initiated | 2023-11-01 |
| Classified | 2023-12-14 |
| Reported by FDA | 2023-12-20 |
| Distributed | Nationwide (US) |
| Quantity | 454 |
| UPC / GTIN / UDI-DI | 17540262160093 |
Product
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Reason for recall
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0551-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.