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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81975

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
December 20, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Healthcare, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

GE Healthcare Centricity Universal Viewer Breast Imaging 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 can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.

Z-0793-2019
Recall number
Z-0793-2019
Initiated
December 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
297 (131 US; 166 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, which could result in an incorrect diagnosis.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

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Inspect official wording and provenance

Reason for recall

When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, which could result in an incorrect diagnosis.

Code information

Centricity Universal Viewer versions 6.0 SP4 or higher with Breast Imaging integrated with either IDI Mammo Workstation version 4.7.x or any version of SenoIris.

Distribution pattern

Worldwide Distribution: US (nationwide) in states of: AZ, CA, CO, DE, FL, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, MT, NE, NJ, NV, NY, OH, PA, PR, SC, SD, TN, TX, VA, VT, and WI; and countries of: Antigua, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Cote d'Ivoire, France, Germany, Guatemala, India, Italy, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Panama, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, and Venezuela.