Z-0731-2014Class II

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

Name: Z-0731-2014 Centricity PACS System versions 3.X and higher and 4.X and higher
Creator: Ge Healthcare It
Published: 2012-09-15
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-09-15 / Terminated / root cause: software

FDA source

Ge Healthcare It began a recall of 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... on 2012-09-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0731-2014
Classification: Class II
Status: Terminated
Initiated: 2012-09-15
Posted: 2014-01-14
Terminated: 2016-06-10
Recalling firm: GE Healthcare
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.
Product code: LLZ System, Image Processing, Radiological
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
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare sent an Important Product Information letter dated September 15, 2012 to affected customers. The letter identified the affected product problem and actions to be taken. GE Healthcare will provide a patch to 3.2.X and 4.0 Systems to remediate the issue. For questions contact your local GEHC-IT service representative.
Quantity in commerce: 748 units
Distribution: Worldwide Distribution - US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY); FOREIGN: Australia, Austria, Belgium, Bermuda, China, Denmark, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Malta, Netherlands, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
Product codes and lots: GE Centricity Software versions 3.X and higher and 4.X and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0731-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0731-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-13

Product code LLZ

K043415Class IICentricity Pacs SystemGe Medical Systems Information Technologies / cleared 2005-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)