GE Healthcare: Medical Device Recall in 2015 - (Recall #: Z-0225-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 28, 2015

Date Posted: November 11, 2015

Recall Number: Z-0225-2016

Event ID: 72472

Reason for Recall:

Inaccurate distance measurements with magnified projection X-ray images.

Status: Terminated

Product Quantity: Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 and higher 1052 units

Code Information:

2067131-001DVD UNIVERSAL VIEWER 5.0 - WEB CLIENT

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated