GE Healthcare, LLC: Medical Device Recall in 2018 - (Recall #: Z-0374-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.

Product Classification:

Class II

Date Initiated: October 11, 2018

Date Posted: November 14, 2018

Recall Number: Z-0374-2019

Event ID: 81418

Reason for Recall:

Synchronization failure

Status: Terminated

Product Quantity: 13

Code Information:

102062-1-Centricity Universal Viewer-00558650/1-357058918; 102406-2-Centricity Universal Viewer-00558667/1-640193933; 102406-2-Centricity Universal Viewer-00558669/1-598891571; 102747-1-Centricity Universal Viewer-00558673 /1-626086029; 103246-1-Centricity Universal Viewer-00558668 / 1-681512983; 11580-1-Centricity Universal Viewer-00558646 / 1-417869653; 2403-7-Centricity Universal Viewer-00558347 1-283597082; 269338-Centricity Universal Viewer-01453050 /HCIT4331279PIW; 4284-1-Centricity Universal Viewer-00558672 / 1-308060186; 4424-2-Centricity Universal Viewer-01474435 / CONCORDIM01474435; Installation tracked via System ID. / HCIT4216808PIW; Installation tracked via System ID. / 2UA443117XAW; and X13479-Centricity Universal Viewer-00043936 / X1347906 / X1347909.

Distribution Pattern:

CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, and WV Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, Ireland, Italy, Mexico, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Switzerland, and Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated