Moderate FDA (Devices)·Z-0021-2014·Announced 2013-10-23

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.

What this means for you

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
Category: Medical Device — Imaging Equipment
Hazard: falling-object
structural-defect

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · GE Healthcare, LLC

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