Midmark Corporation — Class II: Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blo
Midmark Corporation has initiated a Class II recall for the Midmark IQvitals Zone (Model 1-200-03300, Kit 4-000-0624) due to performance issues. Specifically, the device may produce inaccurate blood pressure readings when employing the Linear Deflation Method.
Midmark Corporation, healthcare providers using IQvitals Zone monitors, and clinical staff responsible for adult and pediatric blood pressure monitoring.
Inaccurate blood pressure measurements pose a clinical risk for misdiagnosis or inappropriate treatment. From a regulatory perspective, this indicates a failure in the device's measurement performance standards for its intended use cases, necessitating a formal recall to address the deflation algorithm or hardware interaction.
Verify if the Linear Deflation Method is utilized in current clinical protocols for the affected model. QA teams should coordinate with the manufacturer to implement necessary software or hardware mitigations and ensure affected units are identified via model and kit numbers.
Class II. Reason: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.. Product: Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-03300 with Kit Number: 4-000-0624. Firm: Midmark Corporation (Versailles OH United States). Status: Ongoing.
Open in openFDA / FDA.gov