Company: GE Healthcare It
Date of Enforcement Report: 11/6/2013
Class lI:
PRODUCT
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. 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 Number Z-0116-2014
REASON
GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricity RIS-IC, and a RIS-Driven integration, the “close” button closes the exam in RIS-IC, but does not close the exam in Centricity PACS RA1000 Workstation. 2) Interrupted workflow could break the synchronization between Nuance PowerScribe 360 and Centricity PACS RA1000 Workstation. 3) Interrupted workflow could break the synchronization between Agfa Talk and Centricity PACS RA1000 Workstation.
RECALLING FIRM/MANUFACTURER
GE Healthcare It, Barrington, IL on 6/11/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
623 units
DISTRIBUTION
Nationwide and Internationally
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