GE Medical Systems, LLC

FDA adverse event reports naming GE Medical Systems, LLC as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: GE MEDICAL SYSTEMS, LLC.

Total reports: 1,389
Deaths: 11
Injuries: 652
Malfunctions: 654

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

Recent recalls

2026-07-13Open, ClassifiedProcess control
Optima XR200amx, Mobile Digital-Ready Radiographic System
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
2026-07-13Open, ClassifiedProcess control
Optima XR220amx, Mobile Digital-Ready Radiographic System
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
2026-07-13Open, ClassifiedProcess control
Optima XR240amx, Mobile Digital Radiographic System
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
2026-06-17Open, ClassifiedComponent design/selection
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
2026-06-17Open, ClassifiedComponent design/selection
Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
2026-06-17Open, ClassifiedComponent design/selection
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
2026-06-05Open, ClassifiedDevice Design
Allia IGS 3 Pulse angiographic X-ray system
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
2026-06-05Open, ClassifiedDevice Design
Allia IGS 5 Pulse angiographic X-ray system
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
2026-06-05Open, ClassifiedDevice Design
Allia IGS 7 Pulse angiographic X-ray system
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
2026-06-05Open, ClassifiedDevice Design
Allia IGS Pulse angiographic X-ray system
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

Monitor GE Medical Systems, LLC automatically

DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.

Start Free Trial