510(k) · Cleared
Recalled · Class II · 2021Solar 8000 and Transport Pro with Patient Data Module
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 May 11, 2007 as substantially equivalent to K012467 (General Electric Medical Systems Information Techn, 2002) and 1 other predicate after a 25-day review. Its family tree reaches back 3 generations to 1990. 1 of the 58 devices in its family, counting itself, has a Class I recall. 51 later devices descend from it. It has been recalled 13 times.
- Decided
- May 11, 2007
- Review
- 25 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 13
- Predicates
- 2
Its longest line of descent runs back 3 generations to K900598 (1990). 6 ancestors in all. 51 later devices descend from it, 5 citing it directly. 1 of the 58 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK900598 Tramscope SystemMarquette Electronics, Inc. · 1990
- 2 generations backK993757 SOLAR 7/8000General Electric Medical Systems Information Techn · 2000
- 1 generation backK012467 Solar 8000M SystemGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- This deviceK071073 Solar 8000 and Transport Pro with Patient Data ModuleGe Medical Systems Information Technologies · 2007
- Descendant · cites it directly · 38 of its ownK092027 Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · Recalled
- Descendant · 2 generations on · 32 of its ownK102239 Carescape Monitor B650GE Healthcare Finland Oy · 2010 · Recalled
- Descendant · 3 generations on · 14 of its ownK132533 Carescape Monitor B450GE Healthcare Finland Oy · 2013 · Recalled
- Descendant · 3 generations on · 13 of its ownK131223 Carescape Monitor B650GE Healthcare Finland Oy · 2013 · Recalled
- Descendant · cites it directly · 11 of its ownK190008 Carescape OneGE Healthcare · 2019
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133576 Monitor B404 generations on · 2014
Most influential descendants
Showing 5 of 51 · See all- K092027Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · cites it directly38descendants
- K102239Carescape Monitor B650GE Healthcare Finland Oy · 2010 · 2 generations on32descendants
- K132533Carescape Monitor B450GE Healthcare Finland Oy · 2013 · 3 generations on14descendants
- K131223Carescape Monitor B650GE Healthcare Finland Oy · 2013 · 3 generations on13descendants
- K190008Carescape OneGE Healthcare · 2019 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900598 | Tramscope System | Marquette Electronics, Inc. | 1990 | — |
| −2 | K993757 | SOLAR 7/8000 | General Electric Medical Systems Information Techn | 2000 | — |
| −1 | K012467 | Solar 8000M System | General Electric Medical Systems Information Techn | 2002 | 2 |
| 0 (this device) | K071073 | Solar 8000 and Transport Pro with Patient Data Module | Ge Medical Systems Information Technologies | 2007 | — |
| +1 | K092027 | Carescape Monitor B850 | Ge Medical Systems Information Technologies | 2009 | 9 |
| +2 | K102239 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2010 | 8 |
| +3 | K132533 | Carescape Monitor B450 | GE Healthcare Finland Oy | 2013 | 3 |
| +3 | K131223 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2013 | 4 |
| +1 | K190008 | Carescape One | GE Healthcare | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 1 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 7 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K012467 | Solar 8000M SystemSummary page 1…21 CFR 870.1025 Physiological Patient Monitor (with arrhythmia detection or alarms) Predicate Devices: K012467 Solar 8000M System K042642 Aware Transport Monitor System Device Description:… | 2002 |
| * | K042642 | Aware Transport Monitor System (Includes Aware Pod and Aware Transport Monitor)Summary page 1…onitor (with arrhythmia detection or alarms) Predicate Devices: K012467 Solar 8000M System K042642 Aware Transport Monitor System Device Description: The Patient Data Module can be used with the Solar… | 2004 |
What descends from it? (51)
See all 515 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2021 | Class II | Z-2139-2021 | Software Manufacturing/Software Deployment | Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down. |
| May 18, 2020 | Class II | Z-2424-2020 | Software Design Change | The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection is turned ON, on the monitor, and if an Automated External Defibrillator (AED) is… |
| Aug 31, 2018 | Class II | Z-0522-2019 | 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. |
| Jul 13, 2017 | Class II | Z-0202-2018 | Software Design Change | Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs. |
| Sep 19, 2014 | Class II | Z-0060-2015 | Software design | GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly… |
| Feb 13, 2014 | Class II | Z-1147-2014 | Software design | GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patient Monitor Automatic-View-On-Alarm (AVOA) feature. The Solar 8000M/i AVOA feature will stop functioning if the patient monitor is discharged… |
| Jan 27, 2014 | Class III | Z-1095-2014 | Process control | Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The device mistakenly contains a saline line that is used in our peripheral… |
| Dec 16, 2013 | Class II | Z-0648-2014 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue which affects all Patient Date Modules produced from April 2007 through June 2010, encompassing Fiscal Week 13, 2007 through 26, 2010 due to fluid ingress into the top… |
| Dec 5, 2013 | Class II | Z-0807-2014 | 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-0747-2014 | Device Design | GE Healthcare has recently become aware of a potential safety issue due to intermittent failure of the spring loaded mounting latch of PDMs produced from April 2007 through December 2012. |
| Apr 3, 2013 | Class II | Z-2116-2013 | 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… |
| Feb 17, 2012 | Class II | Z-0524-2013 | Software design | GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care. |
| Oct 5, 2010 | Not classified | Z-0363-2011 | Software design | Transport Pro Monitor stops communication with the CARESCAPE Patient Data Module (PDM) after 414 days of continuous run time. This time will equate to different amounts of real time depending on how much the units is actually in service… |
The 5 latest of 13 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K092027 (Ge Medical Systems Information Technologies, 2009) has gone furthest, with 38 descendants of its own.
- 1 other device also cites its predicate K012467.
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. 2007, 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 Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain…
Read the full statement (435 words)
The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general intensive care unit (ICU), critical care unit, surgical intensive care unit ISICU), respiratory intensive care unit, coronary care unit fCCU), medical intensive care unit (MICUI, pediatric intensive care unit (PICU), or neonatal intensive care unit (NICU).
The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired bythe PDM includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.
The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature and respiration. Both the PDM and TRAM acquisition module acquire, process and store information for all aforementioned parameters.
The Solar 8000i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: electrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous pO2 and pCO2, C02 and respiratory mechanics. The Solar 8000i patient monitoring system is capable of monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, 02, impedance cardiography, electroencephalography and bispectral index. The Solar 8000i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and/or analog data outputs. Information from these devices can be displayed. trended and stored in the monitoring system. The Solar 8000i patient monitoring system also provides physiological data over the UNITY NETWORK TM .
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071073 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071073: Solar 8000 and Transport Pro with Patient Data Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071073
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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