Recall Z-0731-2014— Ge Healthcare It

Name: FDA recall Z-0731-2014
Creator: U.S. Food and Drug Administration
Published: 2012-09-15

Class II · Terminated

Class II FDA medical device recall by Ge Healthcare It, initiated 2012-09-15, terminated 2016-06-10. It names one FDA 510(k) clearance: K043415. Product: Centricity PACS System versions 3.X and higher and 4.X and higher 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.. 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 ter.

Recalling firm: Ge Healthcare It
Classification: Class II
Status: Terminated
Initiated: 2012-09-15
Terminated: 2016-06-10
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

Centricity PACS System versions 3.X and higher and 4.X and higher 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.

Reason for recall

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 ter

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