The Recall Desk
HighFDA (Devices)·Z-0722-2023·Announced 2022-12-28

GE Centricity Universal Viewer 6.0 Medical Imaging Software May Hide Studies

GE Medical Systems' Centricity Universal Viewer 6.0 image display software may hide medical studies from users after IAS tool installation, requiring GE assistance to access hidden images and causing delays in reading diagnostic studies.

What this means for you

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: This is a risk-of-harm product: medical imaging software used for diagnostic purposes (including mammograms for cancer screening) that can hide critical studies from users. Although no illnesses or injuries have been reported, the potential for delayed diagnosis from hidden diagnostic imaging results represents a genuine risk of harm. Per rubric, risk-of-harm products where injury has not yet been reported score as High.

Plain-English summary

GE Medical Systems, LLC is recalling Centricity Universal Viewer 6.0, software used to display medical images including mammograms and data from various imaging sources. After installation of the IAS tool, some medical studies can remain hidden from users without notification. Access to these hidden studies requires GE Healthcare assistance, which can result in delays in reading the studies.

Approximately 236 units have been distributed nationwide to 21 U.S. states and internationally to Austria, Brazil, France, Germany, Ghana, Ireland, Italy, Kuwait, Poland, Saudi Arabia, South Africa, Spain, Switzerland, and the United Kingdom.

Users of affected Centricity Universal Viewer 6.0 installations should contact GE Healthcare if they experience missing or hidden medical studies. Users should verify that all expected studies are visible and accessible in the software.

The recalled product

Product
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Medical Imaging Software
Hazard
Affected units
236

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 (20)

  • Installed Product ID: 100666-1-Centricity Universal Viewer-14194768
  • 100666-1-Centricity Universal Viewer-20084199
  • 4405-1-Centricity Universal Viewer-00558662
  • 4405-1-Centricity Universal Viewer-19508102
  • 405-1-Centricity Universal Viewer-19050922
  • 4405-1-Centricity Universal Viewer-19050921
  • 104535-4-Centricity Universal Viewer-02396030
  • 104535-3-Centricity Universal Viewer-02396026
  • 104535-3-Centricity Universal Viewer-02396027
  • 104535-3-Centricity Universal Viewer-02396028
  • 104535-3-Centricity Universal Viewer-02396029
  • 104535-4-Centricity Universal Viewer-01806096
  • 4406-2-Centricity Universal Viewer-00558683
  • 4446-2-Centricity Universal Viewer-00558643
  • 4407-1-Centricity Universal Viewer-00558657
  • 4407-2-Centricity Universal Viewer-02315681
  • 4406-2-Centricity Universal Viewer-20501355
  • 4318-1-Centricity Universal Viewer-00558703
  • 4318-1-Centricity Universal Viewer-20080694
  • 10227-2-Centricity Universal Viewer-02349137

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

Part of a larger recall action

This product is one of 2 recalled by GE Medical Systems, 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 →

Related recalls

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Same hazard · hidden studies

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