Change Healthcare Canada Company is recalling approximately 454 units of its Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4 systems. The recall was initiated because certain HL7 clinical messages can be incorrectly associated with the wrong patient's medical study. This software defect can lead to medical records containing information from a different patient, which could impact clinical decisions and patient care. Consumers and healthcare facilities using this software should contact the manufacturer for guidance on updates or corrective actions.
The software can misidentify and link clinical data from HL7 messages to the incorrect patient's imaging study. This creates a risk of medical errors, as a healthcare provider might make treatment decisions based on another patient's medical information.
Manufacturer guidance and potential software correction
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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