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Terminated

CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic parameters time synchronized using Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous Blood Pressure (contBP). Furthermore Sympathic Tone and Parasympathic Tone are calculated by power spectral analysis of ECG (heart rate variability) and continuous blood pressure (blood pressure variability) as well as the Baroreceptor Reflex Sensitivity (BRRS). For use by medically trained personnel. It has been designed for diagnoses aiding and must not be used for vital sign monitoring of critically ill patients under absence of additional, suitable self-monitoring devices or medical trained personnel. The device measures continuously the subject's hemodynamic parameters without reporting any diagnosis. It is the physician's responsibility to make proper judgment based on these parameters.

FDA Recall Z-0572-2016 · Posted 2016-01-04

Recalling FirmPartners In Medicine Llc
Recall StatusTerminated
Product CodeDSB
Date Initiated2015-12-01
Date Terminated2017-02-17
Product Quantity28 worldwide 2 monitors distributed in the U.S.

Reason for Recall

Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim persons (overestimation of systolic blood pressure, underestimation of diastolic blood pressure).

Firm Action

CNSystems sent an Urgent Medical Device Recall Safety Notice dated December 1, 2015, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. CNSystems decided to perform a voluntary recall of the affected devices and to return the devices after repair (free of charge). For questions regarding this recall call 314-324-2470.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Nationwide Distribution including MI and CA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K014063TASK FORCE MONITOR 3040Cnsystems Medizintechnik GmbH · 2002-02-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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