Z-0116-2014Class II

The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic...

Name: Z-0116-2014 The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic...
Creator: GE Healthcare It
Published: 2013-06-11
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-06-11 / Terminated / root cause: software

FDA source

GE Healthcare It began a recall of The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals... on 2013-06-11. FDA classified it as Class II and gives the reason as "GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricity RIS-IC, and 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-0116-2014
Classification: Class II
Status: Terminated
Initiated: 2013-06-11
Posted: 2013-10-30
Terminated: 2016-06-10
Recalling firm: GE Healthcare
Product: 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: GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricity RIS-IC, and a RIS-Driven integration, the "close" button closes the exam in RIS-IC, but does not close the exam in Centricity PACS RA1000 Workstation. 2) Interrupted workflow could break the
Root cause tag: software
FDA root cause: Software design
Action: URGENT MEDICAL DEVICE CORRECTION letters dated June 11, 2013 was mailed to all customers alerting them to these potential safety issues. The software was modified to correct these defects and a GE Healthcare service representative will contact each customer to make arrangements for installation of the new software version at no charge to the customer. Customers with concerns or questions about the market action can contact their local GE Healtchcare IT service representative or GE Healthcare's Remote Online Center - Customer Care Center at 1-800-437-1171.
Quantity in commerce: 623 units
Distribution: Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV) and the countries of the UK, Taiwan, Switerzland, Sweden, Spain, Singapore, Saudi Arabia, Netherlands, Malaysia, Korea, Japan, Italy, Israel, India, Hong Kong, Germany, France, Denmark, China, Canada, Bermuda, Beligum and Australia.
Product codes and lots: GE Centricity PACS Versions: 3.1.1.2, 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, 4.0, 4.0.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0116-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0116-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-30

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)