510(k) · Cleared
Recalled · Class II · 2018Modification to Dash 3000, 4000, 5000 Monitor and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jan 11, 2008 as substantially equivalent to K051367 (Ge Medical Systems Information Technologies, 2005) after a 32-day review. Its family tree reaches back 7 generations to 1996. 8 later devices descend from it. It has been recalled 9 times.
- Decided
- Jan 11, 2008
- Review
- 32 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 7 generations to K963644 (1996). 25 ancestors in all, the oldest K904039 (1990). 8 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 6 generations backK974496 A-2000 Eeg Monitor with BisAspect Medical Systems, Inc. · 1998
- 5 generations backK012466 Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn · 2001
- 4 generations backK031694 Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003
- 3 generations backK030267 Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004
- 2 generations backK040183 BISXAspect Medical Systems, Inc. · 2004
- 1 generation backK051367 Patient Monitor, Models Dash 3000, 4000 and 5000Ge Medical Systems Information Technologies · 2005 · Recalled
- This deviceK073462 Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies · 2008
- Descendant · cites it directly · 6 of its ownK080461 Star ST and Arrhythmia Software, Release J.0Philips Medical Systems · 2008
- Descendant · 2 generations on · 4 of its ownK101521 ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010
- Descendant · 3 generations on · 1 of its ownK150352 V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK152305 Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation · 2016
- Descendant · 3 generations on · 0 of its ownK153448 Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems · 2008 · cites it directly6descendants
- K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010 · 2 generations on4descendants
- K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 3 generations on1descendant
- K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation · 2016 · 2 generations on0descendants
- K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −6 | K974496 | A-2000 Eeg Monitor with Bis | Aspect Medical Systems, Inc. | 1998 | — |
| −5 | K012466 | Bis/Eeg Module | General Electric Medical Systems Information Techn | 2001 | — |
| −4 | K031694 | Modification to Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2003 | — |
| −3 | K030267 | Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2004 | — |
| −2 | K040183 | BISX | Aspect Medical Systems, Inc. | 2004 | — |
| −1 | K051367 | Patient Monitor, Models Dash 3000, 4000 and 5000 | Ge Medical Systems Information Technologies | 2005 | 1 |
| 0 (this device) | K073462 | Modification to Dash 3000, 4000, 5000 Monitor and Accessories | Ge Medical Systems Information Technologies | 2008 | — |
| +1 | K080461 | Star ST and Arrhythmia Software, Release J.0 | Philips Medical Systems | 2008 | — |
| +2 | K101521 | ST/AR ST and Arrhythmia Software Model: Release K.O | Philips Medical Systems | 2010 | — |
| +3 | K150352 | V Series Monitoring System (including V12 and V21 Monitors) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +2 | K152305 | Nihon Kohden Afib Detection Program QP-039P | Nihon Kohden Corporation | 2016 | — |
| +3 | K153448 | Passport Series Patient Monitors (Including Passport 8, Passport 12) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051367 | Patient Monitor, Models Dash 3000, 4000 and 5000Summary page 3…for the device, Dash 3000/4000/5000 monitor and accessories is basically the same (with clarification) as compared to the predicate Dash 3000/4000/5000 V6 (K051367). There has been no change to the fundamental scientific technology from the predicate. We have clarified the ind… | 2005 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2018 | Class II | Z-0521-2019 | Software design | 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 | Pending | 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 detection performance. |
| Nov 27, 2013 | Class II | Z-0982-2014 | Software design | 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 Monitoring at the CARESCAPE" CIC Pro… |
| Apr 3, 2013 | Class II | Z-2115-2013 | Nonconforming Material/Component | 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/or Tram Module. ECG and Respiration… |
| Jun 26, 2012 | Class II | Z-0494-2013 | Software design | 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 | Nonconforming Material/Component | 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 communicating with the Dash, resulting in Loss of… |
| Jun 13, 2012 | Class II | Z-0813-2013 | Nonconforming Material/Component | 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 functions intermittently. GE Healthcare… |
| Jul 5, 2011 | Not classified | Z-3075-2011 | Software design | 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 exhibit reboots on some networks when… |
| Oct 11, 2010 | Not classified | Z-0359-2011 | Nonconforming Material/Component | 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 excess EMC emissions, smoking of… |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 25 ancestors have a recall of any class.
- Of its descendants, K080461 (Philips Medical Systems, 2008) has gone furthest, with 6 descendants of its own.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
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…
Read the full statement (214 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073462 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073462: Modification to Dash 3000, 4000, 5000 Monitor and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073462
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026