Z-0034-2014Class II

Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS)

Name: Z-0034-2014 Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS)
Creator: GE Healthcare It
Published: 2012-10-02
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-10-02 / Terminated / root cause: software

FDA source

GE Healthcare It began a recall of Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to... on 2012-10-02. FDA classified it as Class II and gives the reason as "GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side...". 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-0034-2014
Classification: Class II
Status: Terminated
Initiated: 2012-10-02
Posted: 2013-10-21
Terminated: 2016-05-16
Recalling firm: GE Healthcare
Product: Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity Cardio Imaging is intended to assist trained professionals in the viewing, analysis and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians and assistants. Centricity Cardio Imaging is not intended for use in the patient vicinity.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side by side by selecting "Compare Study" from the Study List, or by opening prior studies in the Patient Folder. In these cases, the Viewer differentiates the studies wityh a label (Curr
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare IT mailed an IMPORTANT PRODUCT INFORMATION letter dated October 2, 2012 to the only consignee of this product. The letter notified the customer of the issue, provided temporary instructions on how to use safely use the software until a new software version can be installed, and advises that a software correction will be made available in the near future. Customers who have any questions can contact their local GEHC-IT service representative or call GE Healthcare's Remote Online Center (ROC) Customer Care Center at 1-800-437-1171.
Quantity in commerce: 1 unit
Distribution: USA Nationwide Distribution in the state of OK
Product codes and lots: Software Version: 5.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0034-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0034-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-21

Product code LLZ

K112570Class IICentricity Cardio ImagingGe Healthcare Integrated IT Solutions / cleared 2011-11-30

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)