Recall Z-1486-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge Cardio software.
| Date | Apr 4, 2016 |
| Status | Terminated |
| Reason | Cardio study list does not show STAT studies without refreshing. |
| Root cause | Software design |
| Action | The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued letters dated 7/11/2016. |
| Quantity | 217 sites potentially have the affected versions |
| Distribution | Distribution was nationwide to medical facilities. There was also military distribution. There was no foreign/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051649 | VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 Camtronics Medical Systems, Aug 2, 2005 |