Recall Z-0294-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Fusion Workstation.; Indicated for the transmission and review of radiological images.
| Date | Oct 28, 2011 |
| Status | Terminated |
| Reason | After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values. |
| Root cause | Software design |
| Action | The recalling firm initiated phone calls to affected sites beginning 1/30/2016. |
| Quantity | 13 sites potentially hae the affected version |
| Distribution | Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983401 | FRAMEWAVE WEB Ml Strategies, Inc., Dec 15, 1998 |