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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

1000

Past Year

421

Class I (Serious)

Most Recent

Jan 2026

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 3841–3860 of 4599 recalls

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 Healthcare: LightSpeed VCT 7.2 Vision model numbers: 5212920-300 cons...

Failure to properly document the CTDI in the Technical Reference or User Manual.

FDAOct 1, 2009Nationwide• Ge Healthcare

Ge Healthcare: Discovery CT 750 HD model numbers: 5232083, 5232083-2, 52...

Failure to properly document the CTDI in the Technical Reference or User Manual.

1...191 192193194 195...230

Page 193 of 230Next

FDA

Oct 1, 2009

Nationwide

• Ge Healthcare

ConMed Electrosurgery: * (Box label) SUCTION COAGULATOR 10FR QTY 25 ***** * (Pou...

One production lot of Suction Coagulators received ETO sterilization instead of gamma radiation sterilization.

FDASep 30, 2009CA, FL, GA +18 more• ConMed Electrosurgery

Organogenesis, Inc.: Organogenesis, Inc., Apligraf (draftskin) packaging, Cant...

Unit contaminated with Staphylococcus epidermidis

FDASep 27, 2009Nationwide• Organogenesis, Inc.

General Electric Medical Systems Information Technology: GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH wit...

Potential misuse of the ApexPro Telemetry System and incorrect message and alarm information in the ApexPro Operator's Manual may impact patient safety. When ApexPro Telemetry systems are used with SpO2 oximeters: 1. ApexPro FH Transceiver can operate with the ApexPro FH Xpod connected, but without ECG lead wires attached to the transceiver. This is unintended use of the device that is not do

FDASep 25, 2009Nationwide• General Electric Medical Systems Information Technology

GE Healthcare Integrated IT Solutions: GE Centricity PACS (Picture Archiving and Communication S...

There are potential safety issues, including misdiagnosis or delay in treatment, associated with the use of GE Centricity PACS RA1000 Workstation software that may impact patient safety.

FDASep 25, 2009Nationwide• GE Healthcare Integrated IT Solutions

Gas Boilers (Bosch) – carbon monoxide risk (2009)

Fire/Burn Risk

The recall involves the Buderus GB312 gas-fired, floor standing condensing boilers. Model numbers included in this recall are: 312/90, 312/120, 312/160, 312/200, 312/240 and 312/280. "BUDERUS GB312" is printed on the front of the boiler. The boilers are blue, approximately 60 inches high and between 39 and 55 inches wide.

CPSCSep 23, 2009Nationwide• Bosch Thermotechnology Gmbh, of Germany

Children's Animal Masks and Pendants – Lead Exposure (2009)

Fire/Burn Risk

This recall involves a children's animal mask and four styles of metal pendants. The mask resembles the face of a cat. The pendants have various animated symbols including a dog tag with fire symbol (Bleach), knife and lion symbol (Final Fantasy), Mickey Mouse symbol (Kingdom of Hearts), and a burning sun symbol (Naruto). The pendants were sold with silver-colored chains.

CPSCSep 8, 2009Nationwide• Team Work Trading, of Los Angeles, Calif.

GE Healthcare, LLC: GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage...

The measurement values provided by the GE Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiver, this could lead to an overestimate of the size of the breast lesion that may impact patient treatment and safety. The measurement values for GE images are not affected.

FDAAug 28, 2009AL, AK, AZ +43 more• GE Healthcare, LLC

GE Healthcare, LLC: GE Healthcare IDI Mammo Workstation

FDAAug 28, 2009AL, AK, AZ +43 more• GE Healthcare, LLC

Draeger Medical, Inc.: Drager Surgical Lights Sola 500 and Sola 700.

welded seam may fail

FDAAug 26, 2009Nationwide• Draeger Medical, Inc.

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals: AccuSure, U-100, 31Gauge, 1cc Insulin Syringe, 5/16" (8mm...

Needles separate from the barrels of the syringes

FDAAug 21, 2009Nationwide• Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals: AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8...

Needles separate from the barrels of the syringes

FDAAug 21, 2009Nationwide• Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Child Trailers (Burley Design) – injury risk (2009)

The recalled products are two-wheeled child trailers designed to carry one or two children behind a bicycle. Only the 2009 d'lite ST and 2009 Solo ST trailers with serial numbers that begin with D939 or D948 are included in the recall. The serial number is located in the rear cargo area behind the seat on the lower left rear frame tube. The trailers have "d'lite ST" or "solo ST" screen-printed on the cover.

CPSCAug 19, 2009Nationwide• Burley Design LLC, of Eugene, Ore.

GE Healthcare Integrated IT Solutions: Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 ...

Software error: There is potential safety issue with Centricity Enterprise Archive (EA) 3.0.x software where study split operations are not correctly replicated to a secondary 'shadow' archive.

FDAAug 14, 2009Nationwide• GE Healthcare Integrated IT Solutions

GE Medical Systems, LLC: GE Healthcare Definium 8000.Model # 5131070. 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 Proteus XR/a. Model # 2259988. GE Healthcar...

FDAAug 13, 2009Nationwide• GE Medical Systems, LLC

Ge Healthcare: GE OEC 9900 Elite GSP Fluoroscopes To produce mobile flu...

A software defect - may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. This will also cause the displayed air kerma rate and cumulative air kerma to be inaccurate.

FDAAug 12, 2009Nationwide• Ge Healthcare