Oct

2015

Cl II GE Centricity PACS IW

Company: GE Healthcare.
Date of Enforcement Report 10/14/2015
Class lI:

PRODUCT

Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Recall Number Z-0023-2016

REASON
IImages may be missing when a system parameter MapRoute is set to a value greater than 1.

RECALLING FIRM/MANUFACTURER
GE Healthcare, Barrington, IL on 9/16/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
921 systems are impacted.

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II GE Centricity PACS IW

Amy Sellers

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