Events

Recall of Centricity PACS Workstation

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68092
  • Event Risk Class
    Class 2
  • Event Number
    Z-1665-2014
  • Event Initiated Date
    2014-04-03
  • Event Date Posted
    2014-05-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126929
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • 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.
  • Action
    An URGENT MEDICAL DEVICE CORRECTION letter dated April 3, 2014 was sent to all direct accounts. The letter included instruction to customers to use until the permanent fix for this issue is deployed: 1) Check to see if the DelRejImg task is active and running. a) Log into CA Tool. b) From the Navigation menu, select System Monitor. c) From the pull down menu, select Dbase Maintenance. d) Scroll to the DelRejImg task (this list is alphabetical). e) Review the Task Status. Possible statuses are IDLE or SUSPEND f) If the task status is set to SUSPEND The task is not running. g) If the task is set to IDLE, move to Step 2. 2) Check the Minimum Rejected Image Deletion Time. a) From the Navigation menu, select Sys. Configuration. b) From the pull down menu, select PACS Configuration. c) Scroll to Minimum Rejected Image Deletion Time (this list is alphabetical). d) Review the Value field. e) If the value field is a negative integer (such as the default setting of -1), the Delete Rejected Image process is NOT running and there is no patient safety hazard. If the value field is a positive integer (such as 1 or higher), the Delete Rejected Image process IS running and there is a potential patient safety hazard. 3) A GE Healthcare Service Representative will remove the DelRejImg task from the task table in the Centricity PACS database. This will prevent the DelRejImg task from running, and prevent any rejected images from being deleted. This feature is being removed entirely from the 3.2 release family of Centricity PACS and will be reinstated in a future 4.X workstation release of Centricity PACS. 4) Perform the reject image workflow with only one patient study open at a time. A future release of Centricity PACS will address the unintentional rejected image issue. Until a correction for the unintentional rejected image issue is available, a GE Healthcare service representative will remove the DelRejImg task table in the Centricity PACS database. This will remove the re

Device

Centricity PACS Workstation
  • Model / Serial
    Centricity PACS versions: 3.2; 3.2.0.1; 3.2.0.2; 3.2.1; 3.2.2; 3.2.2.1; 3.2.2.2; 3.2.2.3; 3.2.6; 3.2 SP7; 3.2 SP8; 4.0; 4.0.1; 4.0 SP3
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV, and the countries of Australia, Canada, Chile, France, Germany, India, Ireland, Israel, Italy, Japan, Korea (South), Kuwait, Lebanon, Netherlands, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
  • 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.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Manufacturer Address
    GE Healthcare, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA