Recall Z-2872-2016— Mckesson Medical Imaging Group

Name: FDA recall Z-2872-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-12

Class II · Terminated

Class II FDA medical device recall by Mckesson Medical Imaging Group, initiated 2016-07-12, terminated 2019-11-20. It names one FDA 510(k) clearance: K043146. Product: 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..

Recalling firm: Mckesson Medical Imaging Group
Classification: Class II
Status: Terminated
Initiated: 2016-07-12
Terminated: 2019-11-20
Firm location: Richmond, British Columbia, Canada

510(k) clearances named in this recall

1 on FDA's record

K043146 — HORIZON MEDICAL IMAGINGMckesson Medical Imaging Company·cleared 2005-01-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.