Agency classClass IIOur severity:High FDA (Devices)·Z-1778-2024·Announced 2024-05-15

GE Innova IGS Fluoroscopic X-Ray Systems Adhesive Defect Recall

GE Healthcare is recalling certain Innova IGS x-ray systems due to potential adhesive defects on component bolts. Missing adhesive could cause the detector or x-ray tube to fall during use.

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: FDA Class II recall of medical x-ray equipment with risk-of-harm from potentially falling components. No reported injuries or deaths. Classified as High per the rubric for risk-of-harm products without yet-reported incidents.

Plain-English summary

GE Healthcare is recalling certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS, and Allia Pulse IGS interventional fluoroscopic x-ray systems. The recalled units have serial numbers B3-23-015, B3-23-016, or B3-24-002.

The recall is due to a potential defect in the assembly process where adhesive material might not have been applied to certain bolts on the frontal gantry assembly. This could result in a potential fall of the detector/elevator or x-ray tube.

These units have been distributed worldwide, including in the United States in California, Florida, Georgia, Indiana, Massachusetts, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, and Virginia. International distribution includes Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, and Vietnam.

The recalled product

Product: GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
Manufacturer: GE Medical Systems, SCS
Category: Medical Device — Diagnostic Imaging Equipment
Hazard: structural-defect
equipment-fall
Affected units: 3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

UDI/DI 00840682124614
Serial Numbers: B3-23-015
B3-23-016
B3-24-002

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 7 recalled by GE Medical Systems, SCS 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 7 products in this recall →

Same manufacturer · GE Medical Systems, SCS

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Same hazard · structural defect