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.
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
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.
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.
Healthcare facilities using Stratus Imaging PACS 1.4 software are likely affected. Medical staff handling patient imaging data are at risk of potential misidentification.
Check for version 1.4 of Stratus Imaging PACS software with UDI (01)17540262160093(10)010400. The product was sold by Change Healthcare Canada.
Verify your software version matches the recalled version 1.4 with UDI (01)17540262160093(10)010400.
The recall indicates a potential risk of patient data mix-ups, but it does not cause immediate harm. The software may lead to misdiagnosis if used incorrectly.
Check for version 1.4 with UDI (01)17540262160093(10)010400 on your Stratus Imaging PACS system.
No immediate stop is required. Affected users should check their version and contact Change Healthcare for updates.
We’ve drafted a message you can send Change Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0551-2024 — Change Healthcare Change Healthcare Hello, I own a Change Healthcare that is covered by recall Z-0551-2024 from Change Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
