Z-2579-2016Class II

GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System...

Name: Z-2579-2016 GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System...
Creator: GE Healthcare It
Published: 2012-11-15
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-11-15 / Terminated / root cause: software

FDA source

GE Healthcare It began a recall of 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... on 2012-11-15. FDA classified it as Class II and gives the reason as "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...". 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-2579-2016
Classification: Class II
Status: Terminated
Initiated: 2012-11-15
Posted: 2016-08-17
Terminated: 2017-12-13
Recalling firm: GE Healthcare
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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software design
Action: GE sent an Urgent Medical Device Correction letter dated November 15, 2012. The software has been modified to correct these defects. The modified software was released and installed in user sites under GE Healthcare FMI #85196.
Quantity in commerce: 498 units
Distribution: Worldwide distribution including US nationwide, Puerto Rico, Australia, Austria, Belgium, Bermuda, CANADA, Denmark, Egypt, ENGLAND, France, Germany, India, Ireland, Hong Kong, Korea, Kuwait, Italy, Malta, Netherlands, Portugal, Qatar, Saudi Arabia, SCOTLAND, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, and UK.
Product codes and lots: Centricity PACS versions 3.1.1.x through 3.2.1.x

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2579-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2579-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-17

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)