Recall Z-2620-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge OrthoPACS software.
| Date | May 24, 2017 |
| Status | Terminated |
| Reason | A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations. |
| Root cause | Software design |
| Action | The recalling firm issued a letter dated 5/19/2017 via email on 5/24/2017 or via certified mail if they did not have an email address for the customer. |
| Quantity | 98 sites potentially have the affected versions |
| Distribution | Distribution was made nationwide to medical facilities. There was no foreign/government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.