Company: GE Healthcare
Date of Enforcement Report:6/4/2014
Class lI:
PRODUCT
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, 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 wit the Centricity PACS infrastructure.
Recall Number Z-1665-2014
REASON
It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images are rejected from the active displayed study, images for the previously displayed study may also be rejected. The issue can occur with a previously displayed study that remains open in the background. If one or more, but not all, images in the exam were inadvertently rejected, the image count in the work modes palette identifies fewer images; however, all of the images remain viewable. For newly acquired exams, if the entire exam was inadvertently rejected, the RA1000 will return a message stating “Unable to fetch this exam: No images in the exam”. The images would then need to be resent to PACS from the modality. For historical exams, if the entire exam was inadvertently rejected, the RA1000 will return a message stating “Unable to fetch this exam: No images in the exam”, and the exam is not available on the modality, a GE Healthcare Service representative would need to be contacted to restore the exam on the database. There is a DelRejImg task in Centricity PACS versions 3.2 and higher, that if enabled and running, in conjunction with the inadvertently rejected image issue, poses a potential patient safety hazard due to data loss. If the DelRejImg task runs, the inadvertently rejected images will be permanently deleted from PACS. If you do not have the DelRejImg task running, there is no potential hazard since the inadvertently rejected images remain on the system. The deletion of the inadvertently rejected images could result in missed intervention or mis-diagnosis.
RECALLING FIRM/MANUFACTURER
GE Healthcare, Barrington, IL on 4/3/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
297 units p>
DISTRIBUTION
Nationwide and Internationally
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