# K073462: Modification to Dash 3000, 4000, 5000 Monitor and Accessories

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Jan 11, 2008 after 32 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K963644 (1996). 25 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051367: Patient Monitor, Models Dash 3000, 4000 and 5000, Ge Medical Systems Information Technologies (2005) Summary page 3.

## Most influential descendants
- K080461: Star ST and Arrhythmia Software, Release J.0 (2008), 6 descendants of its own
- K101521: ST/AR ST and Arrhythmia Software Model: Release K.O (2010), 4 descendants of its own
- K150352: V Series Monitoring System (including V12 and V21 Monitors) (2015), 1 descendant of its own
- K152305: Nihon Kohden Afib Detection Program QP-039P (2016), 0 descendants of its own
- K153448: Passport Series Patient Monitors (Including Passport 8, Passport 12) (2016), 0 descendants of its own

## Recalls of this device
- Aug 31, 2018 · Class II · Z-0521-2019: The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
- Dec 5, 2013 · Class II · Z-0806-2014: Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and arrhythmia d
- Nov 27, 2013 · Class II · Z-0982-2014: GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash Port 2 Docking Station: DASH: 1. Dash stops communicating on the Unity Network resulting in Loss of Mo
- Apr 3, 2013 · Class II · Z-2115-2013: GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/o
- Jun 26, 2012 · Class II · Z-0494-2013: GE Healthcare has recently become aware of a potential issue due to an unexpected loss of Custom Automatic NBP Measurement cycling associated with the Dash 3000/4000/5000 patient monitors.
- Jun 13, 2012 · Class II · Z-0814-2013: GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor. This report of correction encompasses the DashPort 2 device, in which the DashPort 2 stops communicatin
- Jun 13, 2012 · Class II · Z-0813-2013: GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on the Dash and DashPort 2 motherboard f
- Jul 5, 2011 · Not classified · Z-3075-2011: GE Healthcare has recently become aware of an issue with the Dash 3000/4000/5000 patient monitors configured with the 802.11b wireless LAN option that may impact patient safety. The Dash monitor may e
- Oct 11, 2010 · Not classified · Z-0359-2011: The power supply board in GE Healthcare Dash 3000, 4000 and 5000 patient monitors may fail due to insufficient solder of a component. Insufficient solder on the power supply board could result in exce

## Indications for use
The Dash TM 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash TM 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operator's manual. The Dash TM 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK TM indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash TM 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs.

Source page: https://510kreport.com/device/K073462
Methodology: https://510kreport.com/methodology