21
Jan
2009

Cl Il Centricity Enterprise Web 3.0 software

0

Company: GE Healthcare Integrated IT Solutions
Date of Enforcement Report 1/21/2009
Class:ll

PRODUCT
Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick access to medical images and related data they need via a web browser, password and a standard PC. Recall # Recall # Z-0870-2009

REASON
Software error: There are two potential safety situations with Centricity Enterprise Web software – a forced log off may occur while using the Centricity Enterprise Web during an open session and Centricity Enterprise Web does not utilize calibration performed on image measurements in Centricity RA1000 Workstation.

RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated December 12, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
742 units

DISTRIBUTION
Nationwide and Internationally

About the author

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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