Recall Z-0329-2022 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
GE Centricity Universal Viewer Zero Footprint Client
| Date | Oct 15, 2021 |
| Status | Terminated |
| Reason | There is a potential to display incomplete patient imaging study. |
| Root cause | Software design |
| Action | The firm issued medical device correction letters dated 10/15/2021 on the same date via traceable means. The letter described the safety issue and actions to be taken. The letter informed the consignee they can continue to use the device by following the instructions provided in the letter until a GE Service Representative can restart their ZFP system. |
| Quantity | 638 devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WA, and WV. The countries of Argentina, Aruba, Australia, Belgium, Bolivia, Brazil, Canada, Chile, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131977 | CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT GE Healthcare, Sep 17, 2013 |