04

Mar

2015

The Centricity PACS Workstation Cl II

0

Company: GE Healthcare It.
Date of Enforcement Report 3/4/2015
Class lI:

PRODUCT

The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure. Recall Number Z-1214-2015

REASON
Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Exam merge in Single Study Mode may fail on “Subquery returned more than one value”. Exam merge in Single Study Mode may fail and leave one exam linked to two or more studies.

RECALLING FIRM/MANUFACTURER
GE Healthcare It, Barrington, IL 2/18/2013 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
128 systems

DISTRIBUTION
Nationwide and Bermuda

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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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