Reported Jan 13, 2016 · Terminated
CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic…
Partners In Medicine LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Partners In Medicine Llc · 11469 Olive Blvd Ste 127 · Saint Louis, MO · 63141-7108
Is this the product you have?
- 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.
- Lot codes and dates
- Serial numbers
003040i-2014-161-014-GG-0000003040i-2015-101-003-GG-0000003040i-2014-161-001-GG-0000003040i-2014-161-002-GG-0000003040i-2014-161-003-GG-0000003040i-2014-161-004-GG-0000003040i-2014-161-005-GG-0000003040i-2014-161-006-GG-0000003040i-2014-161-007-GG-0000003040i-2014-161-008-GG-0000003040i-2014-161-009-GG-0000003040i-2014-161-010-GG-0000003040i-2014-161-011-GG-0000003040i-2014-161-012-GG-0000003040i-2014-161-013-GG-0000003040i-2014-161-015-GG-0000003040i-2014-161-016-GG-0000003040i-2014-161-017-GG-0000003040i-2014-161-018-GG-0000003040i-2014-161-019-GG-0000003040i-2014-161-020-GG-0000003040i-2014-161-021-GG-0000003040i-2014-161-022-GG-0000003040i-2014-161-023-GG-0000003040i-2014-161-024-GG-0000003040i-2014-161-025-GG-0000003040i-2015-101-001-GG-0000and 003040i-2015-101-002-GG-0000
- Serial numbers
- Amount recalled
- 28 worldwide 2 monitors distributed in the U.S.
Where it was sold
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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