Recall Z-2579-2016— GE Healthcare It

Name: FDA recall Z-2579-2016
Creator: U.S. Food and Drug Administration
Published: 2012-11-15

Class II · Terminated

Class II FDA medical device recall by GE Healthcare It, initiated 2012-11-15, terminated 2017-12-13. It names one FDA 510(k) clearance: K043415. Product: GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used 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.. Reason: While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random image-series grouping errors..

Recalling firm: GE Healthcare It
Classification: Class II
Status: Terminated
Initiated: 2012-11-15
Terminated: 2017-12-13
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

GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used 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.

Reason for recall

While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random image-series grouping errors.

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