18
Sep
2008

Cl Il GE Centricity PACS RA1000 Workstation

0

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

PRODUCT
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis; Recall # Z-1826-2008

REASON
A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis.

RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated May 5, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
177 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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