Recall Z-1617-2014 ยท LLZ System, Image Processing, Radiological
Mckesson Medical Immaging
McKesson Radiology-PACS. McKesson Radiology is a medical image and information 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 | May 13, 2014 (initiated Apr 17, 2014) |
| Status | Terminated |
| Reason | High priority alert icon was not displayed in the Study List when there are no Stat studies present. However, the High priority alert icon is visible when studies marked as Stat priority exist in the Study List. |
| Root cause | Software Design Change |
| Action | On April 17, 2014, McKesson Medical Imaging Company initiated a process for applying a software solution to all McKesson Radiology customer systems that may be affected to prevent future occurrences of this issue. The systems with the potentially affected software versions will be corrected without removing the systems from their location. |
| Quantity | 45 |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AL, CA, GA, ID, IL, IA, MD, MS, MO, NE, NV, NH, NY, NC, PA, TN, TX, VT, WA, WV, WY, 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 |