Z-0454-2014Class II

The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed...

Name: Z-0454-2014 The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed...
Creator: Ge Healthcare It
Published: 2012-04-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-04-19 / Terminated / root cause: software

FDA source

Ge Healthcare It began a recall of The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise... on 2012-04-19. FDA classified it as Class II and gives the reason as "GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to DICOM Objects) interface allows for...". 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-0454-2014
Classification: Class II
Status: Terminated
Initiated: 2012-04-19
Posted: 2013-12-05
Terminated: 2017-12-13
Recalling firm: GE Healthcare
Product: The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise Web is not intended for primary diagnosis. The Centricity Enterprise Web is available as a supplemental sub-system to Centricity PACS or as a stand alone Web-based image and information distribution system. The Centricity Enterprise Web provides both the server software and a client application, which utilizes off the shelf browser technology. Centricity Enterprise Web supports several interface protocols which allows the system to be integrated with any image or information systems such as a hospital information system (HIS), radiology information system (RIS), or electronic medical record (EMR), which supports one of the supported integration protocols.
Product code: LMD System, Digital Image Communications, Radiological
Reason for recall: GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to DICOM Objects) interface allows for embedding DICOM images as JPEGs on a web page and is available as a licensed operation on Centricity Web. When rejected images are archived by Centricity PACS to Enterprise Archive, an
Root cause tag: software
FDA root cause: Software design
Action: Urgent Medical Device Correction letters dated April 19, 2013 were sent to customers. The letter requests that customers ensure that their system is configured to disable the WADO interface using the included instructions until the software revision can be installed at their site. The letter further informs customers that updated software will be sent to them for installation.The software has been modified to correct these defects. The modified software will be released and installed in user sites through GE Healthcare FMI# 85206R.
Quantity in commerce: 53 units
Distribution: US Distribution incluidng states of: CA, FL, GA, IA, IL, LA, MO, NJ, NY, OK, TN, WA, and WI.
Product codes and lots: Software versions: 3.0.x

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0454-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0454-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-05

Product code LMD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)