Siemens Healthcare Diagnostics is recalling 13,279 units of its epoc NXS Host blood analysis system due to a software malfunction. The device, which is used by medical professionals for testing blood samples, can incorrectly assign the wrong patient's name to measurement results. No injuries or incidents have been reported, but the defect requires a correction to ensure patient safety and data accuracy.
The software glitch could lead to clinicians misdiagnosing or providing incorrect treatment to patients if blood test results are saved under the wrong patient's file. This error occurs under specific criteria if the user does not manually verify that the patient's name on the screen is correct before saving.
Correction or Update
Software Version Number: 4.14.9. Intended for use by trained medical professionals for the quantitative testing of arterial, venous or capillary whole blood.
Software Version Number: 4.14.9. Intended for use by trained medical professionals for the quantitative testing of arterial, venous or capillary whole blood.
Software Version Number: 4.14.9. Intended for use by trained medical professionals for the quantitative testing of arterial, venous or capillary whole blood.
Software Version Number: 4.14.9. Intended for use by trained medical professionals for the quantitative testing of arterial, venous or capillary whole blood.
Software Version Number: 4.14.9. Intended for use by trained medical professionals for the quantitative testing of arterial, venous or capillary whole blood.
Software Version Number: 4.14.9. Intended for use by trained medical professionals for the quantitative testing of arterial, venous or capillary whole blood.
Software Version Number: 4.14.9. Intended for use by trained medical professionals for the quantitative testing of arterial, venous or capillary whole blood.
Software Version Number: 4.14.9. Intended for use by trained medical professionals for the quantitative testing of arterial, venous or capillary whole blood.
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.
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Sources: FDA iRES · Raw API Response
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