The Recall Desk
HighFDA (Devices)·Z-0572-2016·Announced 2016-01-13

Partners In Medicine Recalls CNSystems Task Force Monitor 3040i for Blood Pressure Errors

Partners In Medicine is recalling 28 CNSystems Task Force Monitor 3040i devices because they may provide incorrect blood pressure readings for some patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device that may provide incorrect diagnostic data (blood pressure), which poses a risk of harm if relied upon for clinical decisions, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Partners In Medicine Llc is recalling 28 units of the CNSystems TASK FORCE MONITOR 3040i, a medical device used to noninvasively measure and display patient hemodynamic parameters. The recall involves 2 monitors distributed in the United States, with nationwide distribution including Michigan and California.

The recall is due to a device non-conformity that may lead to incorrect oscillometric measurement of upper arm blood pressure values in some subjects, mainly tall and slim persons. Specifically, the device may overestimate systolic blood pressure and underestimate diastolic blood pressure. The device is intended for use by medically trained personnel to aid in diagnosis and must not be used for vital sign monitoring of critically ill patients without additional suitable self-monitoring devices or medical personnel.

Consumers and healthcare facilities should contact Partners In Medicine Llc for instructions on how to proceed with the recall. The affected serial numbers are listed in the official FDA recall notice Z-0572-2016.

The recalled product

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 (
Manufacturer
Partners In Medicine Llc
Category
Medical Device — Hemodynamic Monitor
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Related recalls

Same hazard · incorrect measurement

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