Company: GE Healthcare It
Date of Enforcement Report: 2/5/2014
Class lI:
PRODUCT
Centricity PACS System versions 3.X and higher and 4.X and higher_x000D_ Product Usage: 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-0731-2014
REASON
There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X and higher and 4.X and higher when transferring from the source to a destination server. When another process in the destination server attempts to access the same object or table, the transfer process of a particular image may be terminated. Once terminated, the transfer service skips the image being sent, and continues to send the image in the exam.
RECALLING FIRM/MANUFACTURER
GE Healthcare It, Barrington, IL on 9/15/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
748 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
