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.
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 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
- 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
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.
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