Agency classClass IIOur severity:High FDA (Devices)·Z-1886-2019·Announced 2019-07-03

GE Healthcare Recalls Centricity Universal Viewer for Missing Image Warning

GE Healthcare is recalling 292 units of the Centricity Universal Viewer because it may fail to warn users when medical images are missing from exams.

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 used for diagnostic imaging where a software defect could lead to the review of incomplete data. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as no specific injuries or illnesses are cited in the source text.

Plain-English summary

GE Healthcare, LLC is recalling 292 units of the Centricity Universal Viewer with PACS-IW foundation 6.0 (Model number 2090255-001). The device is used to display medical images, including mammograms, and data from various imaging sources.

The recall was initiated because there is a potential that one or more images or image series may be missing from exams without a warning being displayed in the viewer. This lack of warning could result in incomplete medical image reviews.

The affected units were distributed worldwide, including in the United States and numerous international locations such as Canada, the United Kingdom, Germany, and India. Healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue.

The recalled product

Product: Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Medical Imaging Software
Hazard: software-defect
missing-data
Affected units: 292

Distribution

Distributed nationwide across the United States.

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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