Recall Z-2063-2019 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
| Date | Jul 11, 2019 |
| Status | Terminated |
| Reason | Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae). |
| Root cause | Software Design Change |
| Action | Merge Healthcare notified customers on about 07/11/2019 via "Urgent Field Safety Notice" letter. The notice informed customers of two possible issues that may occur on Merge PACS and Merge OrthoPACS: 1. Prior thumbnails may not display in reverse chronological order. 2. Images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Use of an out of order image may result in the implementation of an incorrect or unnecessary treatment plan such as unnecessary medication, change in dosage of existing medication, or unnecessary medical procedures. It may al |
| Quantity | 73 devices |
| Distribution | Nationwide distribution to Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173475 | Merge PACS Merge Healthcare Incorporated, Dec 8, 2017 |