Advantx Lcv+

• • Terminated Z-0908-2017 FDA Class II ·initiated 21 Nov 2016

  GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.

• • Terminated Z-0763-2016 FDA Class II ·initiated 18 Dec 2015 ·on shared 510(k) K960575

  GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor.

• • Terminated Z-0021-2014 FDA Class II ·initiated 16 Aug 2013 ·on shared 510(k) K960575

  GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems.

• • Terminated Z-0616-2010 FDA Unclassified (pre-2012) ·initiated 22 Dec 2009 ·on shared 510(k) K960575

  Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ cardiovascular X-ray imaging systems. Due to potential weakness of some table rotational brakes, an unintended table rotation may occur while the table is locked. This issue could lead to a patient fall if the unintended motion occurs during patient

• • Terminated Z-2359-2008 FDA Unclassified (pre-2012) ·initiated 24 Jun 2008 ·on shared 510(k) K960575

  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 conditions include 1). Due to insufficient securing of the connecting elements, the LCD vertical monitor support may disengage from its arm and fall on the tab

• • Terminated Z-2038-2008 FDA Unclassified (pre-2012) ·initiated 14 Jan 2008

  Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 7 May 1996 Cleared FDA 510(k) K960575
2. 14 Jan 2008 Recall initiated FDA recalls Z-2038-2008
3. 24 Jun 2008 Recall initiated FDA recalls Z-2359-2008
4. 22 Dec 2009 Recall initiated FDA recalls Z-0616-2010
5. 16 Aug 2013 Recall initiated FDA recalls Z-0021-2014
6. 18 Dec 2015 Recall initiated FDA recalls Z-0763-2016
7. 21 Nov 2016 Recall initiated FDA recalls Z-0908-2017

510(k) Number

K960575 ↗

FDA product code

IZI

Device class

Class II

Regulation

21 CFR Part 892.1600

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Other devices filed under FDA product code IZI (System, X-Ray, Angiographic).

• GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM by GE Healthcare
• SPY INTRAOPERATIVE IMAGING SYSTEM by Novadaq Technologies Inc
• EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) by SurgVision GmbH
• VIDEO SYSTEM INTERFACE MODELS by Perkins Mfg. Co.
• SPY FLUORESCENT IMAGING SYSTEM by Novadaq Technologies Inc
• INFRARED 800 with FLOW® 800 Option 7012 by Carl Zeiss Meditec AG
• SPY Elite Intraoperative Perfusion Assessment System by Novadaq Technologies Ulc. (Now A Part of Stryker)
• X-RAY ANGIOGRAPHIC SYSTEM by Camtronics, Ltd.
• BI-N by Xre Corp.
• ANGIOGRAPHIC X-RAY SYSTEM by SIEMENS MEDICAL SOLUTIONS USA, INC.

• Enhanced Boundary for PCCT

  Class II

  FDA 510(k) K253560 Active Cleared 24 Jun 2026

• AIR Recon DL

  Class II

  FDA 510(k) K253808 Active Cleared 13 Aug 2026

• Revolution Vibe

  Class II

  FDA 510(k) K250941 Active Cleared 1 Aug 2025

• GenIQ

  Class II

  FDA 510(k) K143368 Active Cleared 29 Jul 2015

See all devices from GE Medical Systems, Inc. →