Z-0572-2016Class II

CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's...

Name: Z-0572-2016 CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's...
Creator: Partners In Medicine Llc
Published: 2015-12-01
License: https://open.fda.gov/license/

Partners in Medicine LLC / initiated 2015-12-01 / Terminated

FDA source

Partners In Medicine Llc began a recall of CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic parameters time synchronized using... on 2015-12-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0572-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-01
Posted: 2016-01-04
Terminated: 2017-02-17
Recalling firm: Partners in Medicine LLC
Product: 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 code: DSB Plethysmograph, Impedance
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).
FDA 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 in commerce: 28 worldwide 2 monitors distributed in the U.S.
Distribution: Nationwide Distribution including MI and CA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0572-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0572-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-04

Product code DSB

K014063Class IITask Force Monitor 3040Cnsystems Medizintechnik GmbH / cleared 2002-02-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)