Recall Z-1045-2017 ยท LLZ System, Image Processing, Radiological
DICOM GRID INC
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.
| Date | Jan 18, 2017 (initiated Dec 16, 2016) |
| Status | Terminated |
| Reason | A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance. |
| Root cause | Software change control |
| Action | On 12/16/16 a fix is the software issue was conducted via remote cloud system. On 01/11/17 customers were sent Release Notes that addressed the software correction. The issue was resolved and required no further action. |
| Quantity | 209 |
| Distribution | U.S. distribution to the following; TX, FL, NE, CA, WI, AZ, NH, MO, MA, CO, PA, NV, PR, IL, OH, NY, MD, NJ, MN, MI, CT, VA, GA, UT, KS, WA, MI, HI. Foreign distribution to the following; Canada, Spain, Israel, Singapore, Kosovo, Austria, Brazil, Malaysia, Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152977 | DG PACS Dicom Grid, Inc., Jan 25, 2016 |