Spacelabs Healthcare, Ltd. has recalled 142 units of the Sentinel V11 Cardiology Information Management System, specifically Software version 11.6.0. The system contains two software defects: patient demographic fields may automatically fill with information from a previously viewed patient during admission, and ECG test data may be saved into the wrong patient's medical record. Healthcare providers should contact the manufacturer to address these software issues and ensure data integrity.
These software errors can cause a patient's medical record to contain incorrect personal information or test results belonging to someone else. This mix-up could lead to incorrect medical diagnoses or inappropriate clinical treatment decisions based on the wrong data.
Cardiology Information Management System intended to connect to supported medical devices and analyzers to download and manage cardiovascular information.
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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