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Recall Observatory FDA recall evidence

Device product

Centricity PACS Software Version 7.0 SP0.0.4.7

Z-1466-2022

June 14, 2022

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 90525
Status
Terminated
Classification
Class II
Quantity
47 installations
Official record key
device-enforcement:Z-1466-2022

Official wording

Reason: The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.

Code information: Model: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of CO, NV, OH, PA, WA and the countries of Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Oman, Spain, Switzerland, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.