FDA Recall Terminated

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.

Recall: Z-2872-2016 · Initiated July 12, 2016

Recall

Recall Number
Z-2872-2016
Event Number
75194
Firm
Mckesson Medical Imaging Group 10711 Cambie Rdsuite 130 Richmond Canada British Columbia
FEI Number
3003757840
Product Code
LLZ
Status
Terminated
Root Cause
Software design
Initiated
July 12, 2016
Posted
September 22, 2016
Terminated
November 20, 2019

Description

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.

Reason

The STAT priority icon was not displayed in the Study List when the study was opened.

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.

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

Quantity

164 devices