Recall Z-2551-2016 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
| Date | Jul 23, 2015 |
| Status | Terminated |
| Reason | The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm. |
| Root cause | Software design |
| Action | The firm, Merge, sent a "canned" email on 7/23/2015 to its customers which also contained a personal message. The recalling firm issued a second letter entitled "URGENT: MEDICAL DEVICE RECALL" dated 1/27/2016 via e-mail on 1/30/2016. The letters described the product, problem and actions to be taken. The letter informed customers that an upgrade is available. The customers were instructed to call Merge Customer Service at (877) 741-5369 or send an email to support@merge.com to schedule the upgrade-Reference this recall #2016-14. If you decide to decline this maintenance release, complete the |
| Quantity | 9 sites potentially have the affected version |
| Distribution | US Distribution to states of: CA, PA, TX, and MT. |
| 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 |