Recall Z-2318-2013 ยท LLZ System, Image Processing, Radiological
Mckesson Information Solutions LLC
McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.
| Date | Sep 30, 2013 (initiated Sep 4, 2013) |
| Status | Terminated |
| Reason | Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss. |
| Root cause | Software change control |
| Action | Consignees were notified via Urgent Field Safety Notice dated September 4. MMIC Customer support will be contacting customers known to have a multi-server configuration and will implement the configuration change. |
| Quantity | 329 units |
| Distribution | Worldwide Distribution - United States including the territories of Guam and Puerto Rico and the countries of Canada and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043146 | HORIZON MEDICAL IMAGING Mckesson Medical Imaging Company, Jan 4, 2005 |