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GE Medical Systems, LLC

GE Medical Systems, LLC Recalls

All product recalls associated with GE Medical Systems, LLC.

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Recall Summary

Total Recalls

160

Past Year

Class I (Serious)

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 101–120 of 160 recalls

GE Medical Systems, LLC: Omega IV and Omega V tables on GE Innova 3100/3100IQ GE I...

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

FDADec 22, 2009GA, PR• GE Medical Systems, LLC

GE Medical Systems, LLC: Omega IV and Omega V tables on GE Innova 4100/4100IQ GE I...

FDADec 22, 2009GA, PR• GE Medical Systems, LLC

GE Medical Systems, LLC: Omega IV and Omega V tables on GE Innova 2100IQ Digital F...

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FDADec 22, 2009GA, PR• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The M...

GE Healthcare has become aware of an issue with MAC800 laser printouts. When more than one ECG report in the file manager is batch printed in laser print, the potential exists for an incorrect patient identification or name to be displayed on the print out. Misidentification of patient data potentially contributing to delayed or incorrect treatment is then possible.

FDADec 10, 2009Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E...

GE Healthcare has recently become aware of an incorrect operating procedure associated with software versions 9.0.0, 9.0.1, and 9.0.2 of the Voluson E6 or Voluson E8 Diagnostic Ultrasound Systems that may impact patient safety. When using the combination of 2D-CRI and PW with a steered Doppler angle, the displayed velocity scale is incorrect. The consequence can be an underestimation of flow v

FDAOct 22, 2009AL, AR, CA +26 more• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascu...

GE Healthcare has become aware of a potential limit switch failure with Innova 2121IQ and 3131IQ (Biplane) systems that may impact patient safety. A potential limit switch failure could occur due to collision between the lateral plane of Innova Positioner and other equipment in the room. This collision may break the x-ray and positioning switches, and may not allow exam completion. To date, no in

FDAOct 14, 2009Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa H...

GE Healthcare has recently become aware that the use of Confirma, Inc.'s CADstream in conjunction with the GE Healthcare's PURE (Phased Array Uniformity Enhancement) software for dynamic MRI imaging (Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems ) may require a modification to the study preference settings to p

FDAOct 6, 2009Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Healthcare Proteus XR/a. Model # 2259988. GE Healthcar...

Certain GE Radiographic fixed X-ray tables (Proteus XR/a, Revolution XR/d, and Definium 8000) were found to have tabletops that move unexpectedly in a bi-directional mode. In rare cases, a malfunction may occur, which could result in the tabletop brakes falling to engage when the control foot pedal is released to lock the floating tabletop in place.

FDAAug 13, 2009Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Healthcare Revolution XR/d. Model #'s 2259988-2 & 235...

FDAAug 13, 2009Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Healthcare Definium 8000.Model # 5131070. GE Healthcar...

FDAAug 13, 2009Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: Infinia with Hawkeye 4, model numbers: H3000WC and H3000...

Failure to provide the complete User Manual information.

FDAAug 1, 2009Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: Millenium VG with Hawkeye/Discovery VH with Hawkeye, mode...

Failure to provide the complete User Manual information.

FDAAug 1, 2009Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, ...

Failure to provide the complete User Manual information.

FDAAug 1, 2009Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: GE, Innova 2000 The principle system components include a...

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 advance warning and thereby prevent x-ray generation and image processing. Should this occur, the system cannot be restarted.

FDAJul 31, 2009AL, AZ, AR +39 more• GE Medical Systems, LLC

GE Medical Systems, LLC: Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascul...

FDAJul 31, 2009AL, AZ, AR +39 more• GE Medical Systems, LLC

GE Medical Systems, LLC: Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthc...

FDAJul 31, 2009AL, AZ, AR +39 more• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Medical Systems, COMPAX 40E X-ray Systems, Models; 220...

GE Healthcare has recently become aware that table lock safety features, which are provided with Compax 40E X-ray systems, are not always being utilized and has resulted in unintended lateral tabletop movement that may impact patient safety.

FDAJul 30, 2009AL, AK, AZ +43 more• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Healthcare, Uni-Circuit Kit, Adult, Disposable, 1.8 m/...

Breathing circuit inner tube may separate from the rigid connectors under certain conditions. A separation of the inner tube from the connector may prevent adequate gas flow (O2, N2O and anesthetic agents) to the patient. A separation can also cause CO2 re-breathing. This could lead to hypoxia and/or hypercarbia and inadequate anesthesia delivery.

FDAJun 5, 2009Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 0...

GE Healthcare has recently become aware of an issue in the calculations associated with Datex-Ohmeda S/5 Device Interfacing Solution N-DISVENT-02 interfaced between certain Datex-Ohmeda patient monitors (Datex-Ohmeda S/5 Anesthesia Monitor (AM), Datex-Ohmeda S/5 Critical Care Monitor (CCM), Datex-Ohmeda S/5 Compact Anesthesia Monitor (CAM), Datex-Ohmeda S/5 Compact Critical Care Monitor (CCCM)) an

FDAMay 8, 2009AL, AK, AZ +34 more• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Healthcare, CT Perfusion 4 on Advantage Workstation, C...

GE Healthcare has recently become aware of the need to adjust default settings associated with the use of CT Perfusion 4 on the Advantage Workstation, ST and PET/CT consoles that may impact patient safety. The default parameter settings in CT Perfusion 4 may not be optimal in the case of data acquired with longer time sampling intervals such as axial scans with inter scan delay (ISD) greater th

FDAMay 4, 2009AZ, CA, CT +17 more• GE Medical Systems, LLC