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Recall Observatory FDA recall evidence

Device product

Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

Z-0012-2022

August 12, 2021

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 88595
Status
Terminated
Classification
Class II
Quantity
49
Official record key
device-enforcement:Z-0012-2022

Official wording

Reason: A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).

Code information: Centricity Universal Viewer, Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5 GTIN 00840682145794

Distribution pattern: AR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France, Germany, India, Japan, Korea, Kuwait, Saudi Arabia, Singapore, Switzerland, Switzerland, Turkey and United Kingdom

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software anomaly