# K162012: CARESCAPE Central Station V2

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Sep 15, 2016 after 56 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K921669 (1993). 27 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133882: Carescape Central Station (Formally Known as Cic Pro), Ge Medical Systems Information Technologies, Inc. (2014) Summary page 5.
- K842308: 12SSL-SC, Marquette Electronics, Inc. (1984) Summary page 5.
- K092369: 12SL Ecg Analysis Program, Ge Medical Systems Information Technologies (2010) Summary page 5.
- K110132: Muse Cardiology Information System, Ge Medical Systems Information Technologies, Inc. (2011) Summary page 5.

## Most influential descendants
- K201941: Monitor B125, Monitor B105 (2020), 3 descendants of its own
- K213490: Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P (2022), 2 descendants of its own
- K173107: Vios Central Station Monitor Software, Vios Central Server Software (2018), 2 descendants of its own
- K242562: Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (2025), 0 descendants of its own
- K241728: Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 (2025), 0 descendants of its own

## Recalls of this device
- Jul 30, 2026 · Class II · Z-3143-2026: Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.
- Sep 5, 2025 · Class II · Z-0213-2026: GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of
- Sep 5, 2025 · Class II · Z-0214-2026: GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of
- May 10, 2022 · Class II · Z-1265-2022: The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station.
- Jan 28, 2022 · Class II · Z-0808-2022: If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
- Jan 11, 2018 · Class II · Z-0487-2018: CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart.

## Indications for use
The CARESCAPE Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect, display and print information from a network, including patient demographics, physiological parameters and waveforms, alarm annunciation and/or other non-medical information from monitors and telemetry systems. Physiological parameters and waveforms include electrocardiograph (ECG), pulse oximetry (SPO2), invasive blood pressures (IBP), non-invasive blood pressure (NIBP), respiration (RR), ventilator (VNT), carbon dioxide (CO2), oxygen (02), mass spectrometry (Gas), temperature (Temp) and bispectral index (BIS). Beat to beat patient information for parameters and waveforms from the bedside and telemetry systems can be displayed. Patient monitor and telemetry system settings can be adjusted. Parameter values derived from patient data can be calculated, displayed, and printed. The CARESCAPE Central Station supports the ability to access information from GE products and hospital intranet in a web browser format. Additionally, CARESCAPE Central Station supports the ability to access patient information collected from the CARESCAPE network and stored on a network server.

Source page: https://510kreport.com/device/K162012
Methodology: https://510kreport.com/methodology