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Recall Observatory FDA recall evidence

Device product

GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation.

Z-1333-2022

June 08, 2022

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 90454
Status
Ongoing
Classification
Class II
Quantity
1,934 units
Official record key
device-enforcement:Z-1333-2022

Official wording

Reason: Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)

Code information: UDI 00840682102988, Versions 6.0 SP6 through SP11.4

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)