Agency classClass IIOur severity:High FDA (Devices)·Z-0414-2016·Announced 2015-12-23

GE Healthcare Optima IGS 320 Recall for Loss of Displayed Imaging

GE Medical Systems is recalling 45 Optima IGS 320 systems due to a potential safety issue involving non-recoverable 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 procedures, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

GE Medical Systems, LLC is recalling 45 units of the GE Healthcare Optima IGS 320 angiographic X-ray system. The recall is due to a potential safety issue where the system may experience a non-recoverable loss of displayed imaging, also described as a loss of monitor video.

The affected systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular, and non-vascular diagnostic and interventional procedures. The recall covers units distributed worldwide, including in the United States and various international locations.

The source text does not specify the exact corrective action or instructions for consumers or healthcare providers. Users of these systems should contact GE Medical Systems for further information regarding the safety issue and any necessary repairs or replacements.

The recalled product

Product: GE Healthcare Optima IGS 320. 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: 45

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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