Agency classClass IIOur severity:High FDA (Devices)·Z-2098-2013·Announced 2013-09-04

GE Ultrasound ViewPoint 6 Recalled for Incorrect Pulsatility Index Calculations

GE Healthcare is recalling 225 units of the ViewPoint 6 ultrasound system because it may incorrectly calculate venous flow measurements, potentially leading to false high-risk diagnoses for trisomy.

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 medical device with a risk of harm (incorrect diagnostic data leading to false high-risk trisomy assessments) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

GE Healthcare, LLC is recalling 225 units of the GE Ultrasound ViewPoint 6 system. The recall involves software versions 6.2, 6.2.1, 6.3, and 6.3.1. The affected devices were distributed worldwide, including the United States, Puerto Rico, and numerous international locations.

The recall is due to a potential safety issue where the system may incorrectly calculate the pulsatility index value (PIV) for venous flow measurements. Specifically, the ViewPoint calculated Doppler PIV for veins could be incorrect. This error could lead to a false high-risk assessment for trisomy 13, 18, and 21 during obstetric reporting.

The ViewPoint 6 is intended for professional use in medical practices and clinical departments for diagnostic interpretation of images and electronic documentation. It is not intended to be used as an automated diagnosis system. Users should contact GE Healthcare for further instructions regarding the recall.

The recalled product

Product: GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Ultrasound Imaging
Hazard: incorrect-diagnosis
software-error
Affected units: 225

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 (4)

software versions 6.2
6.2.1
6.3
and 6.3.1

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · GE Healthcare, LLC

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