Agency classClass IIOur severity:High FDA (Devices)·Z-1885-2019·Announced 2019-07-03

GE Healthcare Recalls Centricity PACS-IW Universal Viewer Software

GE Healthcare is recalling Centricity PACS-IW with Universal Viewer version 5.0 because medical images may be missing without warning.

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. The hazard involves the potential for missing medical images without warning, which is a risk-of-harm product defect where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

GE Healthcare, LLC is recalling Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001. The recall involves 50 units of the software, which is used by authorized healthcare professionals to display, communicate, store, and process medical images and data from various imaging sources.

The recall is being conducted because there is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer. This defect could affect the viewing, analysis, and diagnostic interpretation of medical images.

The affected units were distributed worldwide, including in the United States, Canada, Brazil, and numerous countries in Europe, Asia, and the Middle East. Healthcare facilities using this specific version of the software should contact GE Healthcare for instructions on how to address the issue.

The recalled product

Product: Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Medical Imaging Software
Hazard: missing-data
diagnostic-error
Affected units: 50

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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