CNSystems TASK FORCE MONITOR 3040i — Class II medical device recall Z-0572-2016
Terminated recall by Partners In Medicine Llc, reported 2016-01-13, distributed nationwide. Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure val
| Recall number | Z-0572-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Partners In Medicine Llc, Saint Louis, MO, United States |
| Recall initiated | 2015-12-01 |
| Classified | 2016-01-04 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2017-02-17 |
| Distributed | Nationwide (US) |
| Serial numbers | 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-2014-161-014-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 and 3 more |
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.
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).
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.