The Centricity Universal Viewer Version 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.
FDA Recall Z-0226-2016 · Posted None
Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeLLZ
Date Initiated2015-09-28
Date Terminated2018-04-11
Product QuantityCentricity Universal Viewer versions 6.0 and higher 5 units
Reason for Recall
Inaccurate distance measurements with magnified projection X-ray images.
Firm Action
An URGENT MEDICAL DEVICE CORRECTION letter was sent to all medical users on 9/28/2015 regarding Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer- Inaccurate distance measurements with magnified projection X-ray images.
GE Healthcare explains that for all projection X-rays, GE Healthcare recommends that the user perform the necessary measurements on the standard contact images, and not rely on measurements made on the magnified views unless the measurements have been independently verified for each X-Ray machine installed or manually calibrated using a radio-opaque fiducial of a known size.
Attention should be given to prior cases acquired before the application of the safety instructions given in this communication as they may be affected by the safety issue.
GE Healthcare will correct all affected systems by providing a software update at no cost to the customer.
GE Healthcare advises customers if they have any questions or concerns regarding the notification, to please contact GE Healthcare Service at
1-800-437-1171 or their local Service Representative.
Root Cause
Software design
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.