Sep

2008

Cl Il GE Centricity AW Suite 2.0 Software

Company: GE Healthcare Integrated IT Solutions
Date of Enforcement Report 9/17/2008
Class:ll

PRODUCT
GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation; for diagnostic image analysis; Recall # Z-1825-2008

REASON
Incorrect measurement of the aortic length in certain cases of aneurysm during the use of the aorta protocol or customized protocol of the Centricity AW Suite 2.0 running on the Centricity RA 1000 or RA600/CA1000 workstations

RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated May 9, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
207 units

DISTRIBUTION
Nationwide and Internationally

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 Il GE Centricity AW Suite 2.0 Software

Amy Sellers

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