Recall Z-0599-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.
| Date | Mar 28, 2016 |
| Status | Terminated |
| Reason | The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing. |
| Root cause | Software design |
| Action | The recalling firm issued a letter dated March 28, 2016 via e-mail or via certified mail to customers. The letter identified the affected product, problem and actions to be taken. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. |
| Quantity | 534 sites potentially have the affected versions |
| Distribution | Worldwide Distribution - US Nationwide including Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082144 | AMICAS PACS, VERSION 6.0 Amicas, Inc., Sep 5, 2008 |