The Recall Desk
HighFDA (Devices)·Z-1973-2015·Announced 2015-07-08

GE Healthcare Recalls Optima IGS 320 Angiographic X-ray Systems

GE Healthcare is recalling three Optima IGS 320 angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.

What this means for you

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 involves a risk-of-harm product (medical device) where the loss of motion capability could impact patient safety, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

GE Healthcare is recalling three units of the Optima IGS 320 angiographic X-ray system. These systems are used to generate fluoroscopic and rotational images of human anatomy for diagnostic, interventional, and image-guided surgical procedures.

The recall is being conducted because GE Healthcare has become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability. This issue affects fluoroscopic interventional imaging systems, including the Innova, Optima, and Discovery lines.

The affected units were distributed worldwide, including in the United States and various international countries. Healthcare facilities and users of these systems should contact GE Healthcare for further instructions regarding the recall and potential corrective actions.

The recalled product

Product
GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Manufacturer
GE Healthcare
Category
Medical Device — Imaging Equipment
Hazard
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 (1)

  • System ID 083016208011415 5512XR0025 5512XR0033

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Part of a larger recall action

This product is one of 13 recalled by GE Healthcare 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 13 products in this recall →

Related recalls

Same manufacturer · GE Healthcare

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Same hazard · loss of motion

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