The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2470-2015·Announced 2015-09-02

GE Healthcare Recalls Centricity Universal Viewer Software Due to Image Loss

GE Healthcare is recalling 26 Centricity Universal Viewer Version 6.0 systems because medical images may be missing when a specific system parameter is set to a value greater than 1.

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 can lead to the loss of medical images, which poses a risk of harm to patient care, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

GE Healthcare is recalling 26 Centricity Universal Viewer Version 6.0 systems. This software is a picture archiving and communications system used in radiology to accept, transfer, display, store, and digitally process medical images. The recall is due to a defect where images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter named MapRoute is set to a value greater than 1.

The affected systems were distributed worldwide, including in the United States (specifically in AK, CA, CO, DE, FL, HI, ID, NY, PA, SD, TN, and TX) and in various international locations such as France, Germany, and India. The specific code associated with the recall is 2090255-001 UV 6.0 Web Client Media Kit, with a date range from June 5, 2015, to the present.

Healthcare facilities using this software should verify their system parameters to ensure the MapRoute value is not set greater than 1 to prevent the loss of medical images. Users should contact GE Healthcare for further instructions on how to resolve this issue.

The recalled product

Product
Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of…
Manufacturer
GE Healthcare
Category
Medical Device — Software
Hazard
Affected units
26

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 2 recalled by GE Healthcare 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 →

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