The Recall Desk
HighFDA (Devices)·Z-0452-2015·Announced 2014-12-24

GE Healthcare Recalls Discovery IGS 740 Imaging Systems Due to Loss of Function

GE Healthcare is recalling Discovery IGS 740 systems because they may lose real-time imaging or motion capabilities due to electromagnetic sensitivity.

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 is classified as FDA Class II, and the hazard involves a loss of function in a medical device used for interventional procedures, which poses a risk of harm even though no specific injuries are reported in the text.

Plain-English summary

GE Healthcare, LLC is recalling the Discovery IGS 740, a medical device used to generate fluoroscopic and rotational images for diagnostic and interventional procedures. The recall is being conducted because the devices may experience a loss of real-time interventional imaging and/or gantry motion. This issue is attributed to the electromagnetic (EM) sensitivity of the grid detection mechanism.

The affected devices were distributed worldwide, including in the United States (specifically California, Colorado, Florida, Missouri, and Pennsylvania) and in Belgium, China, Colombia, France, Greece, Mexico, and Russia. The recall involves one unit identified by System ID 00000646778BU1 and Serial # 190020RX26.

Healthcare facilities and users should contact GE Healthcare for instructions on how to address the defect. The device is indicated for use in patients ranging from newborns to geriatric individuals for cardiovascular, vascular, and non-vascular procedures.

The recalled product

Product
Discovery IGS 740 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 interventional procedures.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
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 (1)

  • Mfg Lot or Serial # System ID 00000646778BU1 190020RX26

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 3 recalled by GE Healthcare, 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 3 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · loss of function

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