# K012171: Modification to: Argus System-Continuous Expert Care Network W/Smart Alrams

- Pathway: 510(k) (Special)
- Applicant: Visicu, Inc.
- Decided: Jul 24, 2001 after 12 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K153156: eCareManager 4.0.1 (2016), 3 descendants of its own
- K171322: eCareManager 4.1 (2017), 2 descendants of its own
- K211046: eCareManager 4.5 (2022), 0 descendants of its own
- K210160: AlertWatch:AC (2021), 0 descendants of its own
- K130234: Nuvon Vitals Charting System (2013), 0 descendants of its own

## Recalls of this device
- Mar 27, 2015 · Class II · Z-0399-2016: A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously se
- Feb 22, 2012 · Not classified · Z-1474-2012: Three versions of software for the eCareManager failed to display anticoagulants on the medications screen. The problem arose due to an unexpected change in the National Drug Data File.

## Indications for use
The VISICU ARGUS System is intended for use in data coliection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. The VISICU ARGUS System is intended to provide patient " information and surveillance _of monitored patients at the point of care location and at a remote supplementary care location through wide area networking technology and dedicated telephone lines. The VISICU ARGUS System is solely intended for use ina hqspital environment. It is not intended to be used in a home environment.

Source page: https://510kreport.com/device/K012171
Methodology: https://510kreport.com/methodology