Z-2469-2015Class II

Centricity PACS-IW with Universal Viewer

Name: Z-2469-2015 Centricity PACS-IW with Universal Viewer
Creator: GE Healthcare
Published: 2015-08-11
License: https://open.fda.gov/license/

GE Healthcare / initiated 2015-08-11 / Terminated / root cause: software

FDA source

GE Healthcare began a recall of Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device... on 2015-08-11. FDA classified it as Class II and gives the reason as "Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1". 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-2469-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-11
Posted: 2015-08-27
Terminated: 2017-01-05
Recalling firm: GE Healthcare
Product: Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. Used in Radiology.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: The firm sent out an Urgent Medical Device Correction letter dated 8/11/2015 to all affected customers. Letter states that No User activity required. GE Healthcare has completed a remote inspection of your system and found that this system parameter is currently set to the default setting of 1. The firm will correct all affected systems by a providing software update. The letter also states that if the customer has any questions they should call GE Healthcare Service at 1-800-437-1171 or their local service representative.
Quantity in commerce: 82 systems
Distribution: Worldwide Distribution - U.S. nationwide in the states of: AK, CA, CO, DE, FL, HI, ID, NY, PA, SD, TN and TX; France, Germany, Greece, India, Israel, Malaysia, Mexico, Northern Ireland (UK), Panama, Poland, Russia, South Africa, Saudi Arabia, Switzerland, Turkey, UAE and Uruguay.
Product codes and lots: Model Number: Centricity PACS-IW with Universal Viewer Version 5.0 through 5.0 SP7 Codes: 2090255-001 UV 6.0 Web Client Media Kit. 05 Jun 15 to present

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2469-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2469-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-26
Z-2470-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-26

Product code LLZ

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