Recall Z-1176-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
| Date | Apr 4, 2016 |
| Status | Terminated |
| Reason | Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment. |
| Root cause | Software design |
| Action | The recalling firm issued a letter dated 3/28/2016 via email on 4/4/2016 or via certified mail if they did not have an email address for the customer. A second letter was issued 7/11/2016 to nonresponders. |
| Quantity | 29 sites have the potentially affected software |
| Distribution | Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082144 | AMICAS PACS, VERSION 6.0 Amicas, Inc., Sep 5, 2008 |