Recall Z-0793-2019 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is inte
| Date | Dec 20, 2018 |
| Status | Terminated |
| Reason | When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, which could result in an incorrect diagnosis. |
| Root cause | Software design |
| Action | On December 21, 2019 GE Healthcare sent "URGENT MEDICAL DEVICE CORRECTION" letters to all their customers stating the following: RE: Centricity Universal Viewer Breast Imaging workflow integration - Patient out of Context Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. Safety Instructions You can continue to use your Centricity Universal Viewer. Follow the below safety instructions while performing your exams. Place the below instructions with your user manual until you receive the addendum. 1.Visually verify th |
| Quantity | 297 (131 US; 166 OUS) |
| Distribution | Worldwide Distribution: US (nationwide) in states of: AZ, CA, CO, DE, FL, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, MT, NE, NJ, NV, NY, OH, PA, PR, SC, SD, TN, TX, VA, VT, and WI; and countries of: Antigua, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Cote d'I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150420 | Centricity Universal Viewer GE Healthcare, May 26, 2015 |