Recall Z-0939-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
DR Systems Unity PACS software, now known as Merge Unity PACS software.
| Date | Oct 15, 2015 |
| Status | Terminated |
| Reason | The software fails to associate to the correct MG image if there are two images for the same view. |
| Root cause | Software design |
| Action | Merge sent an Urgent : Medical Device Recall letter dated July 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Be aware of the following workaround: Customer I User: Ensure both" tome" images are reviewed when more than one is captured for the same view. Merge has a released fix available for this issue. YOUR RESPONSE TO THIS NOTIFICATION IS REQUIRED Please reply using the enclosed form and the return addressed envelope. Your response is required no later than August 2,2016. For further questions regarding |
| Quantity | 9 sites potentially have the effected software |
| Distribution | Distribution was made to medical facilities located in MT, CA, PA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041935 | DR SYSTEMS PACS, RELEASE 6.1 Dr Systems, Inc., Aug 16, 2004 |