Partners In Medicine Llc: Medical Device Recall in 2016 - (Recall #: Z-0572-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 1, 2015

Date Posted: January 13, 2016

Recall Number: Z-0572-2016

Event ID: 72710

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).

Status: Terminated

Product Quantity: 28 worldwide 2 monitors distributed in the U.S.

Code Information:

Serial numbers: 003040i-2014-161-014-GG-0000, 003040i-2015-101-003-GG-0000, 003040i-2014-161-001-GG-0000, 003040i-2014-161-002-GG-0000, 003040i-2014-161-003-GG-0000, 003040i-2014-161-004-GG-0000, 003040i-2014-161-005-GG-0000, 003040i-2014-161-006-GG-0000, 003040i-2014-161-007-GG-0000, 003040i-2014-161-008-GG-0000, 003040i-2014-161-009-GG-0000, 003040i-2014-161-010-GG-0000, 003040i-2014-161-011-GG-0000, 003040i-2014-161-012-GG-0000, 003040i-2014-161-013-GG-0000, 003040i-2014-161-015-GG-0000, 003040i-2014-161-016-GG-0000, 003040i-2014-161-017-GG-0000, 003040i-2014-161-018-GG-0000, 003040i-2014-161-019-GG-0000, 003040i-2014-161-020-GG-0000, 003040i-2014-161-021-GG-0000, 003040i-2014-161-022-GG-0000, 003040i-2014-161-023-GG-0000, 003040i-2014-161-024-GG-0000, 003040i-2014-161-025-GG-0000, 003040i-2015-101-001-GG-0000, and 003040i-2015-101-002-GG-0000

Distribution Pattern:

Nationwide Distribution including MI and CA.

Voluntary or Mandated:

Voluntary: Firm initiated