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.
This recall has been terminated (originally issued September 22, 2016).
- Recall Initiated
- July 12, 2016
- Posted
- September 22, 2016
- Terminated
- November 20, 2019
- Recall Number
- Z-2872-2016
- Quantity
- 164 devices
- Official Source
- View on FDA website ↗
Reason for Recall
The STAT priority icon was not displayed in the Study List when the study was opened.
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
Lot / Code Info
McKesson Radiology versions 12.1.1 and 12.2
Root Cause
Software design
Action Taken
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.