The Recall Desk
HighFDA (Devices)·Z-2102-2018·Announced 2018-06-13

GE Healthcare Recalls Centricity Universal Viewer for Missing Image Series

GE Healthcare is recalling 252 units of the Centricity Universal Viewer because image series may be missing from exams without a user warning.

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: The recall is classified as FDA Class II and involves a risk-of-harm product (medical imaging) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

GE Healthcare is recalling 252 units of the Centricity Universal Viewer, a medical device used to display medical images and data from various imaging sources. The recall is due to a potential issue where one or more image series may be missing from an exam without a user warning being displayed in the Viewer.

The affected devices were distributed worldwide, including in the United States and numerous international countries. The source text does not specify the exact number of reported injuries or illnesses associated with this defect.

Healthcare facilities and users should contact GE Healthcare for instructions on how to address the missing image series issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Centricity Universal Viewer Product Usage: 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, communicated, processed and displayed within the s
Manufacturer
GE Healthcare
Category
Medical Device — Medical Imaging Software
Hazard
Affected units
252

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)

  • 102123-1-Centricity Universal Viewer-00558570
  • 9796-1-Centricity Universal Viewer-00558571
  • 1011-1-Centricity Universal Viewer-00558109
  • 4433-1-Centricity Universal Viewer-00558704
  • 4446-2-Centricity Universal Viewer-00558643
  • 13240-2-Centricity Universal Viewer-00558103
  • 4487-1-Centricity Universal Viewer-01291589
  • 13295-1-Centricity Universal Viewer-01292684
  • 103090-2-Centricity Universal Viewer-00546048
  • 3760-1-Centricity Universal Viewer-00101627
  • 102580-1-Centricity Universal Viewer-00558689
  • 102143-1-Centricity Universal Viewer-00558685
  • 4271-1-Centricity Universal Viewer-00558351
  • 4273-3-Centricity Universal Viewer-00558104
  • 2440-1-Centricity Universal Viewer-00558701
  • 100366-1-Centricity Universal Viewer-00558522
  • 100769-1-Centricity Universal Viewer-01298556
  • 102278-1-Centricity Universal Viewer-00558682
  • 3846-3-Centricity Universal Viewer-00111167
  • 4449-1-Centricity Universal Viewer-00558276

Distribution

Distributed nationwide across the United States.

The notice also names 34 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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