Mindray North America is recalling 2,278 units of the BeneVision N1 Patient Monitor (N1) due to a software defect that can cause an abnormal alarm pause. The recall affects multiple configurations with software versions 01.04.00.01 through 01.06.01.01. These monitors are used in clinical settings to track vital signs; if the alarm system pauses unexpectedly, medical staff may not be alerted to life-threatening changes in a patient's condition. No injuries have been reported, but the defect poses a significant risk to patient safety in critical care environments.
The software defect allows the device's alarm system to enter an abnormal pause state without proper notification. If a patient experiences a medical emergency while the alarm is paused, the device will fail to provide the necessary audible or visual alerts, potentially delaying life-saving medical intervention.
Quantity: 2,278 units total across US and Canadian configurations. Software versions affected: 01.04.00.01, 01.05.00.01, 01.06.00.01, 01.06.01.01.
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.
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Sources: FDA iRES · Raw API Response
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