GE Centricity PACS RA1000 Workstation Cl Il

Company: GE Healthcare Integrated IT Solutions
Date of Enforcement Report 12/17/2008
Class:ll

PRODUCT
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). The Centricity” PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity” PACS infrastructure, Recall # Z-0460-2009

REASON
Software anomalies result in patient safety issues involving patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are used to layout images when displaying a study. If the user does not check the Study Date Time of the exam on the image title bar, then they may interpret the current exam as a historical study and vice versa.

RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington , IL , by letter dated September 25, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
546 units

DISTRIBUTION
Nationwide, Australia, Belgium, Brazil, Canada, Cayman Islands, Chile, Denmark, Ecuador, France, Germany, Hong Kong, Italy, Japan, Korea, Malaysia, Malta, Mexico, New Zealand, Singapore, Spain, Switzerland, Taiwan, United Kingdom and Venezuela

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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