medical Class II Updated 2018-11-14

GE Healthcare, LLC recalls Centricity PACS-IW with Universal Viewer version 5.0.x with

Recalled Product

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.


Hazard / Issue

Synchronization failure

Issued by

FDA

Affected States: CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, WV
Lot/Code Info: 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.
View official government recall

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