Oct

2009

Centricity Enterprise Archive Cl Il

Company:GE Healthcare Integrated IT Solution
Date of Enforcement Report 10/28/2009
Class:ll

PRODUCT
Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software. The software delivers a scalable and flexible DICOM storage solution for Cardiology and Radiology images. Recall # Z-2316-2009

REASON
Software error: There is potential safety issue with Centricity Enterprise Archive (EA) 3.0.x software where study split operations are not correctly replicated to a secondary ‘shadow’ archive.

RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solution, Barrington, IL, by letters dated August 7, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
212 units

DISTRIBUTION
Nationwide, Belgium, Canada, Cayman Islands, China, Denmark, France, Germany, Great Britain, Hong Kong, India, Israel, Italy, Korea, Malaysia, Malta, Mexico, New Zealand, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan and Turkey

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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Centricity Enterprise Archive Cl Il

Amy Sellers

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