Recall Z-0572-2016 ยท DSB Plethysmograph, Impedance
Partners In Medicine Llc
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
| Date | Jan 4, 2016 (initiated Dec 1, 2015) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Mixed-up of materials/components |
| 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. |
| Quantity | 28 worldwide 2 monitors distributed in the U.S. |
| Distribution | Nationwide Distribution including MI and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014063 | TASK FORCE MONITOR 3040 Cnsystems Medizintechnik GmbH, Feb 7, 2002 |