Agency classClass IIOur severity:High FDA (Devices)·Z-0413-2016·Announced 2015-12-23

GE Healthcare Recalls Optima CL323i and IGS 320 X-ray Systems

GE Healthcare is recalling 108 Optima CL323i and Optima IGS 320 angiographic X-ray systems due to a potential loss of displayed imaging.

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 is classified as FDA Class II, and the hazard involves a loss of critical imaging data during medical procedures, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

GE Medical Systems, LLC is recalling 108 units of the Optima CL323i and Optima IGS 320 angiographic X-ray systems. These systems are used to generate fluoroscopic and rotational images of human anatomy for various diagnostic and interventional procedures.

The recall is due to a potential safety issue involving a non-recoverable loss of displayed imaging, specifically a loss of monitor video. This issue could affect the ability to view images during procedures.

The affected units were distributed worldwide, including in the United States and numerous international countries. Healthcare facilities should contact GE Healthcare for further instructions regarding the recall and remediation of the affected systems.

The recalled product

Product: GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and…
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — Imaging Equipment
Hazard: loss-of-imaging
monitor-failure
Affected units: 108

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

Part of a larger recall action

This product is one of 2 recalled by GE Medical Systems, LLC 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 2 products in this recall →

Same manufacturer · GE Medical Systems, LLC

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