Recall Z-2872-2016 ยท LLZ System, Image Processing, Radiological
Mckesson Medical Imaging Group
McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
| Date | Sep 22, 2016 (initiated Jul 12, 2016) |
| Status | Terminated |
| Reason | The STAT priority icon was not displayed in the Study List when the study was opened. |
| Root cause | Software design |
| Action | McKesson sent an Urgent Field Safety Notice on July 12, 2016 to customers with potentially affected software versions. The letter requested that they contact McKesson to acknowledge that they read and understood the Field Safety Notice and to arrange installation of software update/upgrade. Customers with questions were instructed call the McKesson Support department and ask to speak to their Support Manager. For questions regarding this recall call 404-338-3556. |
| Quantity | 164 devices |
| Distribution | Worldwide Distribution - US including AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA WV, WI, WY, and Internationally to Canada, France, Great Britain and Ireland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043146 | HORIZON MEDICAL IMAGING Mckesson Medical Imaging Company, Jan 4, 2005 |