Agency classClass IIOur severity:High FDA (Devices)·Z-1782-2024·Announced 2024-05-15

GE Healthcare X-ray Systems: Potential Adhesive Failure Poses Fall Hazard

GE Healthcare is recalling certain Allia and Discovery IGS x-ray systems due to potential adhesive failure that could cause the detector, elevator, or x-ray tube to fall. No injuries reported.

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 an FDA Class II recall with no reported injuries or incidents. The hazard is a potential structural failure that could result in equipment components falling. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

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 worldwide. These diagnostic imaging systems are used in medical facilities for interventional and diagnostic imaging procedures.

The recall was initiated because adhesive material may not have been properly applied to certain bolts on these systems. This potential adhesive failure could result in the detector assembly, elevator, or x-ray tube falling from the frontal gantry. A falling component could potentially cause injury to patients or medical personnel near the equipment.

The affected systems have been distributed across the United States and internationally. Healthcare facilities operating these systems should contact GE Medical Systems regarding this recall.

The recalled product

Product: GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
Manufacturer: GE Medical Systems, SCS
Category: Medical Device — Diagnostic Imaging Equipment
Hazard: adhesive-failure
fall-hazard
Affected units: 1

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 (2)

UDI/DI 00195278719263
Serial Numbers: M3-23-117

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 failure