Z-0225-2016Class II

The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms)...

Name: Z-0225-2016 The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms)...
Creator: GE Healthcare
Published: 2015-09-28
License: https://open.fda.gov/license/

GE Healthcare / initiated 2015-09-28 / Terminated / root cause: software

FDA source

GE Healthcare began a recall of The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and... on 2015-09-28. FDA classified it as Class II and gives the reason as "Inaccurate distance measurements with magnified projection X-ray images". 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-0225-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-28
Posted: 2015-11-05
Terminated: 2018-04-11
Recalling firm: GE Healthcare
Product: The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Inaccurate distance measurements with magnified projection X-ray images.
Root cause tag: software
FDA root cause: Software design
Action: An URGENT MEDICAL DEVICE CORRECTION letter was sent to all medical users on 9/28/2015 regarding Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer- Inaccurate distance measurements with magnified projection X-ray images. GE Healthcare explains that for all projection X-rays, GE Healthcare recommends that the user perform the necessary measurements on the standard contact images, and not rely on measurements made on the magnified views unless the measurements have been independently verified for each X-Ray machine installed or manually calibrated using a radio-opaque fiducial of a known size. Attention should be given to prior cases acquired before the application of the safety instructions given in this communication as they may be affected by the safety issue. GE Healthcare will correct all affected systems by providing a software update at no cost to the customer. GE Healthcare advises customers if they have any questions or concerns regarding the notification, to please contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
Quantity in commerce: Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 and higher 1052 units
Distribution: Worldwide Distribution-US (nationwide) including the states of AZ, CA, CO, DE, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NJ, NY, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV, and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Ecuador, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kenya, Korea, Malta, Malaysia, Namibia, Netherlands, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, Taiwan, United Arab Emirates, United Kingdom and Venezuela.
Product codes and lots: 2067131-001DVD UNIVERSAL VIEWER 5.0 - WEB CLIENT

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0225-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0225-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-05
Z-0226-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-05

Product code LLZ

K123174Class IICentricity Pacs-Iw with Universal ViewerGE Healthcare / cleared 2012-11-16

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)