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Recall Observatory FDA recall evidence

Device product

Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.

Z-1782-2017

February 18, 2013

Class II

Product summary

Firm
Ge Medical Systems Information T
Event
Event 64545
Status
Terminated
Classification
Class II
Quantity
118
Official record key
device-enforcement:Z-1782-2017

Official wording

Reason: It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder.

Code information: Versions 1.0, 1.1, 2.0, 2.1

Distribution pattern: Nationwide, Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder.