Agency classClass IIOur severity:High FDA (Devices)·Z-0270-2014·Announced 2013-11-20

GE Healthcare Recalls AW Workstations Due to Image Orientation Error

GE Healthcare is recalling AW VolumeShare and AW Server software due to a potential safety issue where images may display in the wrong orientation after rotation.

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 software defect that could lead to misinterpretation of diagnostic images (risk-of-harm product), but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling AW VolumeShare 4, AW VolumeShare 5, and AW Server software products. The recall is due to a potential safety issue involving image orientation within the GSI viewer application. When a user makes a batch and rotates the batch group clockwise 180 degrees (Inferior to Superior), the images may display in the Superior orientation, although the orientation annotation on the image remains correct.

The affected products are medical software systems used for the selection, review, processing, and filming of multi-modality DICOM images. These workstations are used by trained physicians to interpret images for diagnosis, except in the case of mammography images. The recall involves 1,458 units, with 336 distributed in the United States and 1,122 distributed outside the US.

The source text does not specify the corrective action consumers or healthcare providers should take, nor does it report any illnesses or injuries associated with this defect. Users of these systems should monitor for official updates from GE Healthcare or the FDA regarding software patches or further instructions.

The recalled product

Product: AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Medical Software
Hazard: software-defect
misinterpretation

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

Same manufacturer · GE Healthcare, LLC

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