The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1533-2021·Announced 2021-05-12

GE Healthcare Recalls Centricity Universal Viewer for Patient Data Mismatch Risk

GE Healthcare is recalling 112 units of Centricity Universal Viewer software because a specific configuration may display comparison exams from the wrong patient.

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 risk-of-harm product (medical imaging software) where a defect could lead to diagnostic errors, but no injuries or illnesses have been reported, fitting the 'High' severity criteria.

Plain-English summary

GE Healthcare, LLC is recalling 112 units of the Centricity Universal Viewer, a software product intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of medical images. The recall is due to a software defect where the patient jacket may potentially include comparison exams from a different patient.

This issue occurs specifically when the Cross Enterprise Display option is enabled and the Workflow Manager option is used as the PACS worklist to launch the viewer. The affected units were distributed nationwide to 17 states in the United States and internationally to Canada.

No injuries or illnesses have been reported in connection with this recall. Users should check their serial numbers against the list provided in the official recall notice and contact GE Healthcare for instructions on how to resolve the issue.

The recalled product

Product
Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical Imaging Software
Hazard
Affected units
112

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)

  • UDI: 00840682145794
  • Serial Numbers: 105906-2-Centricity Universal Viewer-02312613
  • 6100002127
  • 4049-1-Centricity Universal Viewer-00104520
  • 4049-1-Centricity Universal Viewer-00104521
  • 4049-1-Centricity Universal Viewer-00104522
  • 6100003887
  • 9619-c23f-0fae-4eb2-95f8-1529-7e0f-cb89
  • 103835-2-Centricity Universal Viewer-01370706
  • 103835-2-Centricity Universal Viewer-01370707
  • 103835-2-Centricity Universal Viewer-14549671
  • 103835-2-Centricity Universal Viewer-19676013
  • 103835-2-Centricity Universal Viewer-19676014
  • 103835-2-Centricity Universal Viewer-19676015
  • 1ec2-1d6c-8e6b-4261-a436-2190-812d-b5df
  • 10388-1-Centricity Universal Viewer-14762267
  • 10388-1-Centricity Universal Viewer-17744828
  • 10388-1-Centricity Universal Viewer-17744829
  • 10388-1-Centricity Universal Viewer-17744830
  • 10388-1-Centricity Universal Viewer-17744831

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

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