Recall Z-1426-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
DR Systems Unity PACS software, now known as Merge Unity PACS
| Date | Mar 9, 2017 (initiated Apr 8, 2016) |
| Status | Terminated |
| Reason | Reports were missing demographic header information when they were faxed to referring physicians. |
| Root cause | Software design |
| Action | Merge sent an Urgent : Medical Device Recall letter dated March 28, 2016, to all affected customers via email on April 8, 2016. Nonresponders were issued a second letter dated July 11, 2016. The letter notifies the customer of the issue, makes them aware of a workaround, and informs them a fix is available. 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. The r |
| Quantity | 9 sites potentially have the affected version |
| Distribution | US Distribution was made to medical facilities in CA, MT, PA, and TX. There was no foreign/military/government distribution. |
| 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 |