Recall Z-2532-2016 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
| Date | Jan 30, 2016 |
| Status | Terminated |
| Reason | Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS. |
| Root cause | Software design |
| Action | The recalling firm issued a letter dated 1/28/2016 via e-mail on 1/31/2016 or via certified mail if they did not have an e-mail address for the customer. |
| Quantity | 146 sites may have the affected version for both products |
| Distribution | Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution. |
| FDA record | Open on fda.gov |