GE Healthcare: Medical Device Recall in 2015 - (Recall #: Z-0023-2016)

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:

Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

Product Classification:

Class II

Date Initiated: September 16, 2015

Date Posted: October 14, 2015

Recall Number: Z-0023-2016

Event ID: 72212

Reason for Recall:

Images may be missing when a system parameter MapRoute is set to a value greater than 1.

Status: Terminated

Product Quantity: 921 systems are impacted.

Code Information:

GE Centricity PACS-IW versions 3.5.0 through 3.7.3.9 Sp2, 3.7.3 Spa10, and 4.0.1

Distribution Pattern:

Worldwide Distribution: US (nationwide) including states of: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and countries of: Argentina , Austria, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile , China, Colombia, Costa Rica, Ecuador, Egypt, France, Germany, Great Britain, Hong Kong, Hungary, India, Israel, Italy, Japan,Korea, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Caledonia, Nigeria, Panam¿, Peru, Philippines, Poland, Qatar, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, Venezuela, and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated