Agency classClass IIOur severity:High FDA (Devices)·Z-1980-2015·Announced 2015-07-08

GE Healthcare Recalls Innova IGS 520 Angiographic X-ray Systems

GE Healthcare is recalling 10 Innova IGS 520 angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential safety issue that could lead to loss of motion capability during procedures, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

GE Healthcare is recalling 10 units of the Innova IGS 520 angiographic X-ray system. These systems are used to generate fluoroscopic and rotational images of human anatomy for diagnostic, interventional, and image-guided surgical procedures.

The recall is being issued because GE Healthcare has become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic interventional imaging systems. This issue affects Innova, Optima, and Discovery systems.

The affected units were distributed worldwide, including in the United States (nationwide) and in countries such as Argentina, Belgium, Brazil, Canada, Chile, China, France, Germany, Hong Kong, Hungary, India, Indonesia, Italy, Japan, Russia, the United Kingdom, and Vietnam. Specific serial numbers and system IDs for the affected units are listed in the official recall documentation.

The recalled product

Product: GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Manufacturer: GE Healthcare
Category: Medical Device — Imaging Equipment
Hazard: loss-of-motion
equipment-failure
Affected units: 10

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Part of a larger recall action

This product is one of 13 recalled by GE Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

Same manufacturer · GE Healthcare

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