Agency classClass IIOur severity:High FDA (Devices)·Z-1781-2024·Announced 2024-05-15

GE Allia IGS Fluoroscopic X-Ray Systems Adhesive Bolt Defect

GE Healthcare recalled certain Allia IGS and related fluoroscopic x-ray systems due to potential incomplete adhesive on bolts in the gantry assembly, risking detector or tube failure.

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: This is a Class II FDA medical device recall involving a structural defect with potential for serious injury to patients or staff (equipment falling), though no injuries or deaths have been reported. The hazard is risk-of-harm but theoretical.

Plain-English summary

GE Healthcare has issued a recall of certain Allia IGS 7 OR and related interventional fluoroscopic x-ray systems manufactured by GE Medical Systems, SCS, due to a potential manufacturing defect affecting bolt adhesive application.

According to the FDA, the recalled systems may have incomplete adhesive material applied to certain bolts in the frontal gantry assembly. This defect could result in a potential fall of the detector/elevator or x-ray tube, creating a potential risk to patients and staff.

Two units have been identified in the recall (serial numbers D3-23-026 and D4-24-002). The affected systems have been distributed worldwide, including to multiple U.S. states (California, Florida, Georgia, Indiana, Massachusetts, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia) and internationally (Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam).

The recalled product

Product: GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
Manufacturer: GE Medical Systems, SCS
Category: Medical Device — Fluoroscopic X-Ray System
Hazard: adhesive-defect
equipment-fall
structural-failure
Affected units: 2

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 (3)

UDI/DI 00195278215550
Serial Numbers: D3-23-026
D4-24-002

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 · adhesive defect