19

Dec

2009

Cl Il GE Centricity PACS Workstation Software

0

Company:GE Healthcare Integrated IT Solutions.
Date of Enforcement Report 12/16/2009
Class:ll

PRODUCT
GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment. Recall # Z-0456-2010

REASON
There are potential safety issues, including misdiagnosis or delay in treatment, associated with the use of GE Centricity PACS RA1000 Workstation software that may impact patient safety.

RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated September 23, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,188 units

DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.

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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