Recall Z-0611-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
| Date | May 25, 2016 |
| Status | Terminated |
| Reason | Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed. |
| Root cause | Software design |
| Action | The recalling firm issued a notification letter dated 1/27/2016 via email or via certified mail if the firm did not have an email address for the customer. Nonresponders were issued a second letter dated 5/25/2016 on 5/26/2016. |
| Quantity | 60 sites potentially have the affected versions |
| Distribution | Distribution was made to medical facilities nationwide. Foreign distribution was also made. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092915 | CEDARA WEBACCESS, MODEL: 2.4 Cedara Software Corp., Jun 23, 2010 |