Change Healthcare Stratus Imaging PACS 1.4: Patient Data Mix-Up Risk
Change Healthcare recalls Stratus Imaging PACS 1.4 software due to potential patient data mix-ups. Affected users should check version numbers and contact support for updates.
Lower-risk recall
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
Contact the company
What happened, in plain English
Change Healthcare is recalling Stratus Imaging PACS 1.4 software because it can incorrectly link patient data. This could lead to the wrong patient being associated with medical images, risking misdiagnosis or treatment errors. Read more at govinfonow.com/recall/56968-change-healthcare-stratus-imaging-pacs-1-4-patient-data-mix.
Source Summary by GovInfoNow · govinfonow.com/recall/56968-change-healthcare-stratus-imaging-pacs-1-4-patient-data-mix · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0551-2024
Cite this page
“Change Healthcare Stratus Imaging PACS 1.4: Patient Data Mix-Up Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/56968-change-healthcare-stratus-imaging-pacs-1-4-patient-data-mix. Based on FDA recall #Z-0551-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0551-2024%22&limit=1).
Why it’s dangerous
The software can incorrectly associate patient data from HL7 messages, meaning medical images might be linked to the wrong patient. This could cause misdiagnosis or incorrect treatment if the wrong patient's data is used.
Who’s affected
Healthcare facilities using Stratus Imaging PACS 1.4 software are likely affected. Medical staff handling patient imaging data are at risk of potential misidentification.
How to tell if you have this one
Check for version 1.4 of Stratus Imaging PACS software with UDI (01)17540262160093(10)010400. The product was sold by Change Healthcare Canada.
- Brand
Change Healthcare- Product
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS- Category
Medical device
What to do — step by step
Check Software Version
Verify your software version matches the recalled version 1.4 with UDI (01)17540262160093(10)010400.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution. There was no military/government distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0551-2024 (November 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0551-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.