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Recall Observatory FDA recall evidence

Device product

Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.

Z-0721-2023

October 28, 2022

Class II

Product summary

Firm
GE Medical Systems, LLC
Event
Event 91159
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-0721-2023

Official wording

Reason: There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.

Code information: Installed Product ID: YP3150-Centricity Universal Viewer-01639018

Distribution pattern: Nationwide distribution to CA, CO, DE, FL, IA, IL, MA, MI, MN, MO, MS, MT, ND, NJ, NY, OK, OR, SD, TX, WI, WV, WY. International distribution to Austria, Brazil, France, Germany, Ghana, Ireland, Italy, Kuwait, Poland, Saudi Arabia, South Africa, Spain, Switzerland, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.