—#168670

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.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123174
Affected 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.

Why it was recalled

Synchronization failure

Root cause (FDA determination)

Software design

Action the firm took

On October 12, 2018 GE Healthcare send recall notification to all their consignees with the following instructions; If you do not use a Diagnostic viewer (e.g. Centricity Universal Viewer Zero Footprint Client or any 3rd party dicom viewer) connected directly to the same Centricity EA to display images for diagnostic purposes, your system is not affected by the safety issue. If you do use a Diagnostic viewer (e.g. Centricity Universal Viewer Zero Footprint Client or any 3rd party dicom viewer) connected directly to the same Centricity EA to display images for diagnostic purposes, please contact GE Healthcare service representative immediately. GE Healthcare will assist you in determining if your system is affected and, if necessary, will assist you with a solution to confirm that study updates are made in the Enterprise Archive, until GE Healthcare can install a correction on your system. GE Healthcare will provide a correction that will be installed by a GE service engineer. A GE Healthcare representative will contact you to arrange for the correction. This activity will be performed at no cost to you. Contact Information If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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.

Timeline

Recall initiated: 2018-10-11
Terminated: 2023-03-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168670. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.