GE Medical Systems, LLC
94 recalls on record · Latest: Dec 17, 2025
FDA Devices Moderate Aug 14, 2024
Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging Syst…
FDA Devices Moderate Aug 14, 2024
SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging…
FDA Devices Moderate Aug 14, 2024
Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance …
FDA Devices Moderate Aug 14, 2024
SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 14, 2024
3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16.0_V03, HD23.0_V03; Nuclear M…
FDA Devices Moderate Aug 14, 2024
SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 14, 2024
Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only
FDA Devices Moderate Dec 28, 2022
Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid…
FDA Devices Moderate Dec 28, 2022
Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ…
FDA Devices Moderate Dec 28, 2022
Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid…
FDA Devices Moderate Dec 28, 2022
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imagin…
FDA Devices Moderate Dec 28, 2022
B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
FDA Devices Moderate Dec 28, 2022
B125M Patient Monitor, REF 6160000-004-XXXXXX
FDA Devices Moderate Dec 28, 2022
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
FDA Devices Moderate Dec 28, 2022
Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid)…
FDA Devices Moderate Oct 24, 2018
GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T…
FDA Devices Moderate Oct 24, 2018
GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-…
FDA Devices Moderate Oct 3, 2018
Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.…
FDA Devices Moderate Aug 1, 2018
MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (previously cle…
FDA Devices Moderate Aug 23, 2017
Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to support high reso…
FDA Devices Moderate Aug 23, 2017
Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, hi…
FDA Devices Moderate Aug 23, 2017
Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, h…
FDA Devices Moderate Aug 23, 2017
1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body m…
FDA Devices Moderate Aug 23, 2017
1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system is a whole …
FDA Devices Moderate Aug 23, 2017
SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to suppor…
FDA Devices Moderate Jun 1, 2016
GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
FDA Devices Moderate May 4, 2016
GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal…
FDA Devices Moderate Apr 20, 2016
GE Healthcare, Aisys CS2 anesthesia..
FDA Devices Moderate Apr 13, 2016
SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high si…
FDA Devices Moderate Mar 16, 2016
Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed …
FDA Devices Moderate Mar 16, 2016
LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole…
FDA Devices Moderate Mar 16, 2016
LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X…
FDA Devices Moderate Mar 16, 2016
Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed …
FDA Devices Moderate Mar 16, 2016
LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray …
FDA Devices Moderate Mar 16, 2016
LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Com…
FDA Devices Moderate Feb 17, 2016
GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
FDA Devices Moderate Feb 17, 2016
GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
FDA Devices Moderate Feb 17, 2016
GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
FDA Devices Moderate Feb 17, 2016
Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Adv…
FDA Devices Moderate Jan 27, 2016
GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It…
FDA Devices Moderate Jan 27, 2016
GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. I…
FDA Devices Moderate Dec 23, 2015
GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in gener…
FDA Devices Moderate Dec 16, 2015
GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomograph…
FDA Devices Moderate Nov 11, 2015