Agency classClass IIOur severity:High FDA (Devices)·Z-1779-2017·Announced 2017-04-19

GE Healthcare Recalls Vivid Ultrasound Systems Due to Patient Selection Error

GE Healthcare is recalling Vivid E95, E90, and E80 ultrasound systems because slow search times can cause operators to select the wrong patient, potentially leading to misdiagnosis.

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 risk of misdiagnosis (a risk-of-harm product) where no injuries have yet been reported, fitting the criteria for a score of 3.

Plain-English summary

GE Healthcare, LLC is recalling specific Vivid E95, E90, and E80 ultrasound systems (models H45581DC, H45581LB, and H45581DA). The recall involves 971 units, with 412 located in the United States and 559 outside the US. The affected systems were distributed to numerous countries, including the United Kingdom, Canada, Australia, and various nations in Europe, Asia, and the Middle East.

The recall is due to a software issue where a patient other than the intended one may be incorrectly selected by the operator when the DICOM Worklist search response time is slow. This can result in incorrect patient information appearing on the screen during an exam. If the operator does not detect the error, images from the actual patient may be stored under the wrong patient's record after the exam, which could lead to misdiagnosis.

GE Healthcare reports that there have been no injuries reported as a result of this issue. Healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue and ensure patient data integrity.

The recalled product

Product: Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Ultrasound Systems
Hazard: misdiagnosis
data-integrity

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · GE Healthcare, LLC

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