510(k) · Cleared
Recalled · Class II · 2015Innova 4100, Innova 3100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Aug 26, 2004 as substantially equivalent to K960575 (GE Medical Systems, 1996) after a 27-day review. Its family tree reaches back 1 generation to 1996. It has been recalled 34 times.
- Decided
- Aug 26, 2004
- Review
- 27 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 34
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960575 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK960575 Advantx LCV+GE Medical Systems · 1996 · Recalled
- This deviceK042053 Innova 4100, Innova 3100Ge Medical Systems, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960575 | Advantx LCV+ | GE Medical Systems | 1996 | 6 |
| 0 (this device) | K042053 | Innova 4100, Innova 3100 | Ge Medical Systems, Inc. | 2004 | — |
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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K960575 | Advantx LCV+ Our OCR of the scanned summary read K860575, FDA’s number for Yeast Identification Panel (American Micro Scan). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GE Advantx LCV+”. | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2015 | Class II | Z-0763-2016 | Nonconforming Material/Component | GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor. |
| Dec 11, 2013 | Class II | Z-1163-2014 | Software design | GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle which may result in the loss of real-time interventional… |
| Jan 21, 2013 | Class II | Z-0947-2013 | Nonconforming Material/Component | A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging systems. |
| Dec 20, 2011 | Class II | Z-1318-2013 | Nonconforming Material/Component | While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries… |
| Oct 21, 2011 | Class II | Z-1142-2013 | Labeling design | As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff… |
| Aug 24, 2011 | Not classified | Z-0133-2012 | Nonconforming Material/Component | A potential weakness on the monitor suspension end-stop device may impact user safety. The end-stops may break if the monitor-suspension is repeatedly pushed with excessive force on the end rails. |
| May 16, 2011 | Class II | Z-1616-2013 | Software design | GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems. |
| Jun 3, 2010 | Not classified | Z-1922-2010 | Device Design | GE Healthcare has become aware of a potential loss of gantry and table motions affecting Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ systems with InnovaIQ Table that may impact patient safety. |
| Jun 3, 2010 | Not classified | Z-1923-2010 | Device Design | GE Healthcare has become aware of a potential loss of gantry and table motions affecting Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ systems with InnovaIQ Table that may impact patient safety. |
| Jun 3, 2010 | Not classified | Z-1921-2010 | Device Design | GE Healthcare has become aware of a potential loss of gantry and table motions affecting Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ systems with InnovaIQ Table that may impact patient safety. |
| Jul 31, 2009 | Not classified | Z-2241-2009 | Component design/selection | GE Healthcare has recently became aware of a potential power supply failure with the Innova 2000, 3100 and 4100 systems that may impact patient safety. A potential power supply failure inside the GE equipment cabinet could occur with no… |
| Jul 31, 2009 | Not classified | Z-2242-2009 | Component design/selection | GE Healthcare has recently became aware of a potential power supply failure with the Innova 2000, 3100 and 4100 systems that may impact patient safety. A potential power supply failure inside the GE equipment cabinet could occur with no… |
| Apr 16, 2009 | Not classified | Z-0135-2010 | Device Design | Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room… |
| Apr 16, 2009 | Not classified | Z-0137-2010 | Device Design | Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room… |
| Jul 25, 2008 | Not classified | Z-2438-2008 | Device Design | The charger and / or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down. |
| Jul 25, 2008 | Not classified | Z-2437-2008 | Device Design | The charger and / or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down. |
| Jun 24, 2008 | Not classified | Z-2358-2008 | Employee error | GE Healthcare has become aware of 2 potential conditions that could occur with the MAVIG GD Monitor Suspension that is used with Advantx-E, Innova 2000, 21000IQ, 3100/3100IQ, 4100/4100IQ and 2121 IQ/3131IQ cardiovascular systems. The two… |
| Jun 24, 2008 | Not classified | Z-2356-2008 | Employee error | GE Healthcare has become aware of 2 potential conditions that could occur with the MAVIG GD Monitor Suspension that is used with Advantx-E, Innova 2000, 21000IQ, 3100/3100IQ, 4100/4100IQ and 2121 IQ/3131IQ cardiovascular systems. The two… |
| Jun 17, 2008 | Not classified | Z-1475-2009 | Process control | GE Healthcare has become aware that a few customers have experienced an unusual occurrence of system lockups on Innova single plane cardiovascular X-ray imaging systems while using the image auto-archiving function. when occurring during… |
| Jun 17, 2008 | Not classified | Z-1476-2009 | Process control | GE Healthcare has become aware that a few customers have experienced an unusual occurrence of system lockups on Innova single plane cardiovascular X-ray imaging systems while using the image auto-archiving function. when occurring during… |
| May 19, 2008 | Not classified | Z-1521-2008 | Software design | GE Healthcare has become aware of a potential condition that may impact operator or patient safety. One customer has reported that inability to terminate X-ray exposure after releasing the hand switch control (located in the control room). |
| Mar 6, 2008 | Not classified | Z-1093-2009 | Software design | GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, and a system reset is required to… |
| Mar 6, 2008 | Not classified | Z-1092-2009 | Software design | GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, and a system reset is required to… |
| Jan 30, 2008 | Not classified | Z-0475-2009 | Software design | Software error, computer: GE Healthcare has became aware of an issue with Error Management affecting the Innova 2100, 3100/3100 IQ & 4100/4100IQ. It was reported that when the foot switch was pressed, the live monitor screen was blank and… |
| Jan 30, 2008 | Not classified | Z-0474-2009 | Software design | Software error, computer: GE Healthcare has became aware of an issue with Error Management affecting the Innova 2100, 3100/3100 IQ & 4100/4100IQ. It was reported that when the foot switch was pressed, the live monitor screen was blank and… |
| Nov 15, 2007 | Not classified | Z-0691-2008 | Device Design | Frozen Image Problems: During an acquisition (fluoro and/or record), there have been cases reported where an image became "frozen" on the DL (digital leader acquisition system) live monitor screen. In such cases, the system continued to… |
| Nov 15, 2007 | Not classified | Z-0692-2008 | Device Design | Frozen Image Problems: During an acquisition (fluoro and/or record), there have been cases reported where an image became "frozen" on the DL (digital leader acquisition system) live monitor screen. In such cases, the system continued to… |
| Oct 21, 2007 | Not classified | Z-1516-2008 | Nonconforming Material/Component | Incorrect dose data: GE Healthcare has found that after 6 days and 4 hours without performing a system reset or a system reboot (turning it off/on), the displayed dose data on these systems (Innova 3100 / Innova 4100 with Bolus option)… |
| Oct 21, 2007 | Not classified | Z-1517-2008 | Nonconforming Material/Component | Incorrect dose data: GE Healthcare has found that after 6 days and 4 hours without performing a system reset or a system reboot (turning it off/on), the displayed dose data on these systems (Innova 3100 / Innova 4100 with Bolus option)… |
| Mar 26, 2007 | Not classified | Z-0871-2007 | Other | Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function on Innova Digital (located in control… |
| Mar 26, 2007 | Not classified | Z-0870-2007 | Other | Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function on Innova Digital (located in control… |
| Mar 26, 2007 | Not classified | Z-0869-2007 | Other | Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function on Innova Digital (located in control… |
| Mar 26, 2007 | Not classified | Z-1044-2007 | Other | Caution on the non-detection of small invasive objects/devices, which project out from the skin surfaces (e.g. biopsy or other needles) while using the Innova Sense software option designed for patient contouring. Usage of Innova Sense… |
| Mar 26, 2007 | Not classified | Z-1043-2007 | Other | Caution on the non-detection of small invasive objects/devices, which project out from the skin surfaces (e.g. biopsy or other needles) while using the Innova Sense software option designed for patient contouring. Usage of Innova Sense… |
The 5 latest of 34 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K960575.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OWB
22in 2025
2007high 24 (2021) · low 3 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
2007high 221 (2026) · low 37 (2012)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
2007high 42 (2026) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
2007high 14,008 (2025) · low 0 (2008)2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The two Digital Fluoroscopic Imaging Systems are indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. These devices are not intended for mammography applications. The Bolus Chasing option submitted here is intended to perform subtracted angiography in real time of the lower limbs for diagnostic purpose.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K042053 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042053: Innova 4100, Innova 3100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042053
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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