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Ge Medical Systems, Llc Recalls

91 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Ge Medical Systems, Llc.

91Total Recalls
6Critical
127,791Units Affected
Feb 3, 2026Most Recent
All Recalls

Every Ge Medical Systems, Llc Recall

Sorted by most recent. Click any recall for full details.

91 recalls
High RiskFDA
Ge Medical Systems, Llc
Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Medical Devices·469 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use only
Medical Devices·6 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Medical Devices·206 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Medical Devices·81 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
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 ...
Medical Devices·1,607 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
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 Reson...
Medical Devices·1,817 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
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 Magneti...
Medical Devices·484 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System
Medical Devices·3 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
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_V0...
Medical Devices·0 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
Medical Devices·23 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
Medical Devices·826 affected·Nov 16, 2022
High RiskFDA
Ge Medical Systems, Llc
B125M Patient Monitor, REF 6160000-004-XXXXXX
Medical Devices·5,962 affected·Nov 16, 2022
CriticalFDA
Ge Medical Systems, Llc
Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, tes...
Cardiac Devices·5,145 affected·Nov 10, 2022
CriticalFDA
Ge Medical Systems, Llc
Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric;...
Cardiac Devices·1,400 affected·Nov 10, 2022
CriticalFDA
Ge Medical Systems, Llc
Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, tes...
Cardiac Devices·5,649 affected·Nov 10, 2022
CriticalFDA
Ge Medical Systems, Llc
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultra...
Cardiac Devices·7,931 affected·Nov 10, 2022
High RiskFDA
Ge Medical Systems, Llc
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
Medical Devices·236 affected·Oct 28, 2022
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCI...
Medical Devices·5,200 affected·Jun 7, 2018
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED ...
Medical Devices·5,200 affected·Jun 7, 2018
CriticalFDA
Ge Medical Systems, Llc
Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Numbe...
Cardiac Devices·516 affected·Jun 6, 2018
High RiskFDA
Ge Medical Systems, Llc
MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (pr...
Cardiac Devices·54 affected·Mar 30, 2018
High RiskFDA
Ge Medical Systems, Llc
Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to suppo...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed to support high re...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed to support high r...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
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 ...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
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...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner design...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patien...
Respiratory Devices·952 affected·Mar 15, 2016
High RiskFDA
Ge Medical Systems, Llc
SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolut...
Cardiac Devices·16 affected·Mar 1, 2016
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Aisys CS2 anesthesia..
Medical Devices·5,496 affected·Feb 17, 2016
High RiskFDA
Ge Medical Systems, Llc
Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-r...
Diagnostic Devices·817 affected·Feb 10, 2016
High RiskFDA
Ge Medical Systems, Llc
LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for he...
Diagnostic Devices·25 affected·Feb 10, 2016
High RiskFDA
Ge Medical Systems, Llc
LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and ...
Diagnostic Devices·324 affected·Feb 10, 2016
High RiskFDA
Ge Medical Systems, Llc
Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-r...
Diagnostic Devices·522 affected·Feb 10, 2016
High RiskFDA
Ge Medical Systems, Llc
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...
Diagnostic Devices·104 affected·Feb 10, 2016
High RiskFDA
Ge Medical Systems, Llc
LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole bo...
Diagnostic Devices·1 affected·Feb 10, 2016
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Diagnostic Devices·2,389 affected·Dec 23, 2015
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Diagnostic Devices·126 affected·Dec 23, 2015
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Diagnostic Devices·895 affected·Dec 23, 2015
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia...
Respiratory Devices·84 affected·Dec 15, 2015
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesi...
Respiratory Devices·2 affected·Dec 15, 2015
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriat...
Surgical Devices·45 affected·Nov 13, 2015
High RiskFDA
Ge Medical Systems, Llc
MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
Surgical Devices·23 affected·Sep 23, 2015