Recall Z-0664-2017 ยท OUG Medical Device Data System
Merge Healthcare, Inc.
Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications
| Date | Jan 30, 2016 |
| Status | Terminated |
| Reason | Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software. |
| Root cause | Software design |
| Action | The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/30/2016. Nonresponders were issued a second letter dated 5/25/2016 via email on 5/26/2016. |
| Quantity | 324 sites potentially have the affected version |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.