GE Healthcare Recalls X-ray Systems Due to Missing Monitor Screws
GE Healthcare is recalling specific X-ray imaging systems because missing screws in the overhead video monitor suspension could create a safety hazard.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific defect involves missing screws in a monitor suspension, which is a mechanical issue without reported injuries or deaths in the source text.
Plain-English summary
GE Healthcare, LLC is recalling its Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging systems. The recall is due to a potential safety issue involving missing screws in the overhead Video Monitor Suspension of these devices.
The affected units are intended for general purpose diagnostic fluoroscopy and radiography studies. A total of 2,184 units are involved in this recall, with 1,063 units distributed in the United States and 1,121 units distributed outside the US. The products were distributed worldwide, including in the US (nationwide including DC and Puerto Rico, except ND, SD, and VT) and numerous international countries.
Healthcare facilities should check their equipment for the specific serial numbers listed in the official recall notice. If a unit is affected, the facility should contact GE Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.
- Manufacturer
- GE Healthcare, LLC
Distribution
Related recalls
Same manufacturer · GE Healthcare, LLC
See all →- HighGE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
- HighGE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
- HighGE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
- HighGE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
- SevereGE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
FDA (Devices) · 2022-07-27
Same hazard · falling object
See all →- SevereLithonia Lighting Recalls RSX Luminaires with Adjustable Tilt Arms
CPSC · 2026-10-22
- HighMaquet PowerLED 300 Concealed Lighting System Recalled for Detachment Risk
FDA (Devices) · 2026-09-30
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighFord F-650 SD Recall: Liftgate Platform Deck Pins May Break
NHTSA · 2026-08-20
- SevereTerex Digger Derrick Trucks Recalled for Weld Defect
NHTSA · 2026-08-17
Similar recalls
- HighGE Healthcare Recalls Cardiovascular X-ray Systems Due to Locking Nut Issue
FDA (Devices) · 2013-03-20
- HighGE Healthcare Recalls Innova X-ray Systems for Unexpected Power Loss
FDA (Devices) · 2014-03-19
- HighGE Healthcare Recalls Cardiovascular X-ray Systems Due to Exposed Wires
FDA (Devices) · 2013-03-20
- HighGE Healthcare Recalls Innova 3100IQ Angiographic X-ray Systems
FDA (Devices) · 2015-07-08
- HighGE Healthcare Recalls Innova 2100IQ Angiographic X-ray Systems
FDA (Devices) · 2015-07-08
- HighGE Healthcare Recalls Innova Fluoroscopic Systems Due to Relay Failure
FDA (Devices) · 2013-05-22