# K042053: Innova 4100, Innova 3100

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Aug 26, 2004 after 27 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 34 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960575 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960575: Advantx LCV+, GE Medical Systems (1996). 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+”. Summary page 2.

## Recalls of this device
- Dec 18, 2015 · Class II · Z-0763-2016: 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: 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
- Jan 21, 2013 · Class II · Z-0947-2013: 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-
- Dec 20, 2011 · Class II · Z-1318-2013: 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 distribu
- Oct 21, 2011 · Class II · Z-1142-2013: 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 a
- Aug 24, 2011 · Not classified · Z-0133-2012: 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: 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: 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: 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: 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: 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 e
- Jul 31, 2009 · Not classified · Z-2242-2009: 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 e
- Apr 16, 2009 · Not classified · Z-0135-2010: 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 info
- Apr 16, 2009 · Not classified · Z-0137-2010: 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 info
- Jul 25, 2008 · Not classified · Z-2438-2008: 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: 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: 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/3
- Jun 24, 2008 · Not classified · Z-2356-2008: 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/3
- Jun 17, 2008 · Not classified · Z-1475-2009: 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-arch
- Jun 17, 2008 · Not classified · Z-1476-2009: 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-arch
- May 19, 2008 · Not classified · Z-1521-2008: 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
- Mar 6, 2008 · Not classified · Z-1093-2009: 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, a
- Mar 6, 2008 · Not classified · Z-1092-2009: 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, a
- Jan 30, 2008 · Not classified · Z-0475-2009: 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,
- Jan 30, 2008 · Not classified · Z-0474-2009: 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,
- Nov 15, 2007 · Not classified · Z-0691-2008: 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
- Nov 15, 2007 · Not classified · Z-0692-2008: 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
- Oct 21, 2007 · Not classified · Z-1516-2008: 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 31
- Oct 21, 2007 · Not classified · Z-1517-2008: 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 31
- Mar 26, 2007 · Not classified · Z-0871-2007: 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
- Mar 26, 2007 · Not classified · Z-0870-2007: 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
- Mar 26, 2007 · Not classified · Z-0869-2007: 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
- Mar 26, 2007 · Not classified · Z-1044-2007: 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 patien
- Mar 26, 2007 · Not classified · Z-1043-2007: 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 patien

## Indications for use
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.

Source page: https://510kreport.com/device/K042053
Methodology: https://510kreport.com/methodology