Recall Z-1665-2014— GE Healthcare

Name: FDA recall Z-1665-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-03

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2014-04-03, terminated 2015-06-05. It names one FDA 510(k) clearance: K043415. 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.. 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.

Recalling firm: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2014-04-03
Terminated: 2015-06-05
Firm location: Barrington, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K043415 — CENTRICITY PACS SYSTEMGe Medical Systems Information Technologies·cleared 2005-01-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.