Agency classClass IIOur severity:High FDA (Devices)·Z-0588-2019·Announced 2018-12-19

GE LOGIQ E10 Ultrasound System Recalled for Potential Burn Injury

GE Healthcare is recalling 103 LOGIQ E10 Ultrasound Systems because a trans-esophageal probe may overheat, posing a risk of burn injury to patients.

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 involves a risk-of-harm product (burn injury) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

GE Healthcare, LLC is recalling 103 GE LOGIQ E10 Ultrasound Systems (Model #530000E10) due to a potential safety issue. The recall involves 64 units in the United States and 39 units distributed internationally to Austria, Denmark, Finland, and Norway.

The recall is issued because there is a potential for an undetected over-temperature condition on the trans-esophageal (TEE) probe. This malfunction could lead to a possible burn injury to the patient during use. The devices are intended for use by qualified physicians for various ultrasound evaluations, including fetal/obstetrics, abdominal, and cardiac imaging.

Healthcare facilities and consumers with these specific serial numbers should stop using the affected trans-esophageal probes immediately. GE Healthcare is managing the recall to address the defect and prevent potential harm.

The recalled product

Product: GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Ultrasound System
Hazard: burn-injury
overheating

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 (20)

Serial numbers 500055US7
500103US7
500022US7
500059US7
00066US7
500083US7
500057US7
500130US7
500114US7
500105US7
500111US7
500039US7
500132US7
500064US7
500128US7
500131US7
500063US7
500062US7
500104US7
500139US7

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Same manufacturer · GE Healthcare, LLC

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