Z-2872-2016 Class II Terminated
FDA device recall Z-2872-2016 was initiated by Mckesson Medical Imaging Group on July 12, 2016 and is designated Class II. Reason for recall: The STAT priority icon was not displayed in the Study List when the study was opened. The recall status is terminated (terminated November 20, 2019). Affected quantity: 164 devices.
Recall Details
- Product Type
- Devices
- Report Date
- September 28, 2016
- Initiation Date
- July 12, 2016
- Termination Date
- November 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 164 devices
Product 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 for Recall
The STAT priority icon was not displayed in the Study List when the study was opened.
Distribution Pattern
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
Code Information
McKesson Radiology versions 12.1.1 and 12.2